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: 21CFR720

 

  Page 194-198

 

         TITLE 21--FOOD AND DRUGS

 

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

 

 PART 720--VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT AND COSMETIC RAW MATERIAL
 COMPOSITION STATEMENTS--Table of Contents

 

 Sec.

 720.1  Who should file.

 720.2  Times for filing.

 720.3  How and where to file.

 720.4  Information requested about cosmetic products.

 720.5   Reserved

 720.6  Amendments to statement.

 720.7  Notification of person submitting cosmetic product ingredient

           statement.

 720.8  Confidentiality of statements.

 720.9  Misbranding by reference to filing or to statement number.

 

     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 10060, Mar. 15, 1974, unless otherwise noted.

 

 Sec. 720.1  Who should file.

 

     Either the manufacturer, packer, or distributor of a cosmetic

 product is requested to file Form FDA 2512 (``Cosmetic Product

 Ingredient Statement''), whether or not the cosmetic product enters

 interstate commerce. This request extends to any foreign manufacturer,

 packer, or distributor of a cosmetic product exported for sale in any

 State as defined in section 201(a)(1) of the Federal Food, Drug, and

 Cosmetic Act. No filing fee is required.

 

  57 FR 3129, Jan. 28, 1992

 

 Sec. 720.2  Times for filing.

 

     Within 180 days after forms are made available to the industry, Form

 FDA 2512 should be filed for each cosmetic product being commercially

 distributed as of the effective date of this part. Form FDA 2512 should

 be filed within 60 days after the beginning of commercial distribution

 of any product not covered within the 180-day period.

 

  57 FR 3129, Jan. 28, 1992

 

 Sec. 720.3  How and where to file.

 

     Forms FDA 2512 and FDA 2514 (``Discontinuance of Commercial

 Distribution of Cosmetic Product Formulation'') are 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 or

 delivered to: Cosmetic Product Statement, Food and Drug Administration,

 Department of Health and Human Services, Washington, DC 20204, according

 to the instructions provided with the forms.

 

  57 FR 3129, Jan. 28, 1992

 

 Sec. 720.4   Information requested about cosmetic products.

 

     (a) Form FDA-2512 requests information on:

     (1) The name and address, including post office ZIP code of the

 person (manufacturer, packer, or distributor) designated on the label of

 the product.

     (2) The name and address, including post office ZIP code, of the

 manufacturer or packer of the product if different from the person

 designated on the label of the product, when the manufacturer or packer

 submits the information requested under this paragraph.

     (3) The brand name or names of the cosmetic product.

     (4) The cosmetic product category or categories.

     (5) The ingredients in the product.

     (b) The person filing Form FDA-2512 should:

     (1) Provide the information requested in paragraph (a) of this

 section.

     (2) Have the form signed by an authorized individual.

     (3) Provide poison control centers with ingredient information and/

 or adequate diagnostic and therapeutic procedures to permit rapid

 evaluation and treatment of accidental ingestion or other accidental use

 of the cosmetic product.

     (4) Provide ingredient information (and, when requested, ingredient

 samples) to a licensed physician who, in connection with the treatment

 of a patient, requests assistance in determining whether an ingredient

 in the cosmetic product is the cause of the problem for which the

 patient is being treated.

     (c) One or more of the following cosmetic product categories should

 be

 

   Page 195

 

 cited to indicate the product's intended use.

     (1) Baby products. (i) Baby shampoos.

     (ii) Lotions, oils, powders, and creams.

     (iii) Other baby products.

     (2) Bath preparations. (i) Bath oils, tablets, and salts.

     (ii) Bubble baths.

     (iii) Bath capsules.

     (iv) Other bath preparations.

     (3) Eye makeup preparations. (i) Eyebrow pencil.

     (ii) Eyeliner.

     (iii) Eye shadow.

     (iv) Eye lotion.

     (v) Eye makeup remover.

     (vi) Mascara.

     (vii) Other eye makeup preparations.

     (4) Fragrance preparations. (i) Colognes and toilet waters.

     (ii) Perfumes.

     (iii) Powders (dusting and talcum) (excluding aftershave talc).

     (iv) Sachets.

     (v) Other fragrance preparations.

     (5) Hair preparations (noncoloring).

     (i) Hair conditioners.

     (ii) Hair sprays (aerosol fixatives).

     (iii) Hair straighteners.

     (iv) Permanent waves.

     (v) Rinses (noncoloring).

     (vi) Shampoos (noncoloring).

     (vii) Tonics, dressings, and other hair grooming aids.

     (viii) Wave sets.

     (ix) Other hair preparations.

     (6) Hair coloring preparations. (i) Hair dyes and colors (all types

 requiring caution statement and patch test).

     (ii) Hair tints.

     (iii) Hair rinses (coloring).

     (iv) Hair shampoos (coloring).

     (v) Hair color sprays (aerosol).

     (vi) Hair lighteners with color.

     (vii) Hair bleaches.

     (viii) Other hair coloring preparations.

     (7) Makeup preparations (not eye). (i) Blushers (all types).

     (ii) Face powders.

     (iii) Foundations.

     (iv) Leg and body paints.

     (v) Lipstick.

     (vi) Makeup bases.

     (vii) Rouges.

     (viii) Makeup fixatives.

     (ix) Other makeup preparations.

     (8) Manicuring preparations. (i) Basecoats and undercoats.

     (ii) Cuticle softeners.

     (iii) Nail creams and lotions.

     (iv) Nail extenders.

     (v) Nail polish and enamel.

     (vi) Nail polish and enamel removers.

     (vii) Other manicuring preparations.

     (9) Oral hygiene products. (i) Dentifrices (aerosol, liquid, pastes,

 and powders).

     (ii) Mouthwashes and breath fresheners (liquids and sprays).

     (iii) Other oral hygiene products.

     (10) Personal cleanliness. (i) Bath soaps and detergents.

     (ii) Deodorants (underarm).

     (iii) Douches.

     (iv) Feminine hygiene deodorants.

     (v) Other personal cleanliness products.

     (11) Shaving preparations. (i) Aftershave lotions.

     (ii) Beard softeners.

     (iii) Men's talcum.

     (iv) Preshave lotions (all types).

     (v) Shaving cream (aerosol, brushless, and lather).

     (vi) Shaving soap (cakes, sticks, etc.).

     (vii) Other shaving preparation products.

     (12) Skin care preparations, (creams, lotions, powder, and sprays).

 (i) Cleansing (cold creams, cleansing lotions, liquids, and pads).

     (ii) Depilatories.

     (iii) Face and neck (excluding shaving preparations).

     (iv) Body and hand (excluding shaving preparations).

     (v) Foot powders and sprays.

     (vi) Moisturizing.

     (vii) Night.

     (viii) Paste masks (mud packs).

     (ix) Skin fresheners.

     (x) Other skin care preparations.

     (13) Suntan preparations. (i) Suntan gels, creams, and liquids.

     (ii) Indoor tanning preparations.

     (iii) Other suntan preparations.

     (d) Ingredients in the product should be listed as follows:

     (1) A list of each ingredient of the cosmetic product in descending

 order of predominance by weight (except that the fragrance and/or flavor

 may be designated as such without naming each individual ingredient when

 the manufacturer or supplier of the fragrance and/or flavor refuses to

 disclose ingredient data).

 

   Page 196

 

     (2) An ingredient should be listed by the name adopted by the Food

 and Drug Administration (FDA) for the ingredient pursuant to

 Sec. 701.3(c) of this chapter.

     (3) In the absence of a name adopted by FDA pursuant to

 Sec. 701.3(c) of this chapter, its common or usual name, if it has one,

 or its chemical or technical name should be listed.

     (4) If an ingredient is a mixture, each ingredient of the mixture

 should be listed in accordance with paragraphs (d)(2) and (d)(3) of this

 section, unless such mixture is a formulation voluntarily registered on

 Form FDA 2512, in which case such mixture should be identified as

 ``fragrance,'' ``flavor,'' ``fragrance and flavor'' or ``base

 formulation,'' as appropriate, and by stating its FDA-assigned cosmetic

 product ingredient statement number.

     (5) When the manufacturer or supplier of a fragrance and/or flavor

 refuses to disclose ingredient data, the fragrance and/or flavor should

 be listed as such. The nonconfidential listing of the product name and/

 or trade name or name of the manufacturer or supplier of each

 proprietary fragrance and/or flavor mixture is optional.

     (e) A separate Form FDA-2512 should be filed for each different

 formulation of a cosmetic product. However, except for the hair coloring

 preparations listed in paragraph (c)(6) of this section for which a

 statement for each shade of such product is required, a single Form FDA-

 2512 may be filed for two or more shades of a cosmetic product where

 only the amounts of the color additive ingredient used are varied or in

 the case of flavors and fragrances where only the amounts of the flavors

 and fragrances used are varied.

 

 (Information collection requirements in this section were approved by

 the Office of Management and Budget (OMB) and assigned OMB control

 number 0910-0030)

 

  39 FR 10060, Mar. 15, 1974, as amended at 46 FR 38073, July 24, 1981;

 57 FR 3129, Jan. 28, 1992

 Sec. 720.5   Reserved

 

 Sec. 720.6  Amendments to statement.

 

     Changes in the information requested under Secs. 720.4 (a)(3) and

 (a)(5) on the ingredients or brand name of a cosmetic product should be

 submitted by filing an amended Form FDA 2512 within 60 days after the

 product is entered into commercial distribution. Other changes do not

 justify immediate amendment, but should be shown by filing an amended

 Form FDA 2512 within a year after such changes. Notice of discontinuance

 of commercial distribution of a cosmetic product formulation should be

 submitted by Form FDA 2514 within 180 days after discontinuance of

 commercial distribution becomes known to the person filing.

 

 (Information collection requirements in this section were approved by

 the Office of Management and Budget (OMB) and assigned OMB control

 number 0910-0030)

 

  57 FR 3130, Jan. 28, 1992

 

 Sec. 720.7  Notification of person submitting cosmetic product

           ingredient statement.

 

     When Form FDA 2512 is received, FDA will either assign a permanent

 cosmetic product ingredient statement number or a Food and Drug

 Administration (FDA) reference number in those cases where a permanent

 number cannot be assigned. Receipt of the form will be acknowledged by

 sending the individual signing the statement an appropriate notice

 bearing either the FDA reference number or the permanent cosmetic

 product ingredient statement number. If the person submitting Form FDA

 2512 has not complied with Secs. 720.4 (b)(1) and (b)(2), the person

 will be notified as to the manner in which the statement is incomplete.

 

  57 FR 3130, Jan. 28, 1992

 

 Sec. 720.8  Confidentiality of statements.

 

     (a) Data and information contained in, attached to, or included with

 Forms FDA 2512 and FDA 2514, and amendments thereto are submitted

 voluntarily to the Food and Drug Administration (FDA). Any request for

 confidentiality of a cosmetic ingredient submitted with such forms or

 separately will be handled in accordance with the procedure set forth in

 this section and in Sec. 20.44 of this chapter. The request for

 confidentiality will also be subject to the provisions of Sec. 20.111 of

 this chapter, as well as to the

 

   Page 197

 

 exemptions in subpart D of part 20 of this chapter and to the

 limitations on exemption in subpart E of part 20 of this chapter.

     (b) Any request for confidentiality of the identity of a cosmetic

 ingredient should contain a full statement, in a well-organized format,

 of the factual and legal grounds for that request, including all data

 and other information on which the petitioner relies, as well as

 representative information known to the petitioner that is unfavorable

 to the petitioner's position. The statement of the factual grounds

 should include, but should not be limited to, scientific or technical

 data, reports, tests, and other relevant information addressing the

 following factors that FDA will consider in determining whether the

 identity of an ingredient qualifies as a trade secret:

     (1) The extent to which the identity of the ingredient is known

 outside petitioner's business;

     (2) The extent to which the identity of the ingredient is known by

 employees and others involved in petitioner's business;

     (3) The extent of measures taken by the petitioner to guard the

 secrecy of the information;

     (4) The value of the information about the identity of the claimed

 trade secret ingredient to the petitioner and to its competitors;

     (5) The amount of effort or money expended by petitioner in

 developing the ingredient; and

     (6) The ease or difficulty with which the identity of the ingredient

 could be properly acquired or duplicated by others.

     (c) The request for confidentiality should also be accompanied by a

 statement that the identity of the ingredient for which confidentiality

 is requested has not previously been published or disclosed to anyone

 other than as provided in Sec. 20.81(a) of this chapter.

     (d) FDA will return to the petitioner any request for

 confidentiality that contains insufficient data to permit a review of

 the merits of the request. FDA will also advise the petitioner about the

 additional information that is necessary to enable the agency to proceed

 with its review of the request.

     (e) If, after receiving all of the data that are necessary to make a

 determination about whether the identity of an ingredient is a trade

 secret, FDA tentatively decides to deny the request, the agency will

 inform the person requesting trade secrecy of its tentative

 determination in writing. FDA will set forth the grounds upon which it

 relied in making this tentative determination. The petitioner may

 withdraw the records for which FDA has tentatively denied a request for

 confidentiality or may submit, within 60 days from the date of receipt

 of the written notice of the tentative denial, additional relevant

 information and arguments and request that the agency reconsider its

 decision in light of both the additional material and the information

 that it originally submitted.

     (f) If the petitioner submits new data in response to FDA's

 tentative denial of trade secret status, the agency will consider that

 material together with the information that was submitted initially

 before making its final determination.

     (g) A final determination that an ingredient is not a trade secret

 within the meaning of Sec. 20.61 of this chapter constitutes final

 agency action that is subject to judicial review under 5 U.S.C. Chapter

 7. If suit is brought within 30 calendar days after such a

 determination, FDA will not disclose the records involved or require

 that the disputed ingredient or ingredients be disclosed in labeling

 until the matter is finally determined in the courts. If suit is not

 brought within 30 calendar days after a final determination that an

 ingredient is not a trade secret within the meaning of 21 CFR 20.61, and

 the petitioner does not withdraw the records for which a request for

 confidentiality has been denied, the records involved will be made a

 part of FDA files and will be available for public disclosure upon

 request.

 

  51 FR 11444, Apr. 3, 1986, as amended at 57 FR 3130, Jan. 28, 1992

 

 Sec. 720.9  Misbranding by reference to filing or to statement number.

 

     The filing of Form FDA 2512 or assignment of a number to the

 statement does not in any way denote approval by the Food and Drug

 Administration of

 

   Page 198

 

 the firm or the product. Any representation in labeling or advertising

 that creates an impression of official approval because of such filing

 or such number will be considered misleading.

 

  57 FR 3130, Jan. 28, 1992