§ 710.3 21 CFR Ch. I (4–1–99 Edition)
within 30 days after the operation be- § 710.7 Inspection of registrations. gins. A copy of the Form FD–2511 filed by the registrant will be available for in- § 710.3 How and where to register. spection at the Food and Drug Admin- Form FD–2511 (‘‘Registration of Cos- istration, Department of Health and metic Product Establishment’’) is ob- Human Services, Washington, DC 20204. tainable on request from the Food and Drug Administration, Department of § 710.8 Misbranding by reference to Health and Human Services, Wash- registration or to registration num- ington, DC 20204, or at any Food and ber. Drug Administration district office. Registration of a cosmetic product The completed form should be mailed establishment or assignment of a reg- to Cosmetic Product Establishment istration number does not in any way Registration, Food and Drug Adminis- denote approval of the firm or its prod- tration, Department of Health and ucts by the Food and Drug Administra- Human Services, Washington, DC 20204. tion. Any representation in labeling or advertising that creates an impression § 710.4 Information requested. of official approval because of registra- Form FD–2511 requests information tion or possession of a registration on the name and address of the cos- number will be considered misleading. metic product establishment, including post office ZIP code; all business trad- § 710.9 Exemptions. ing names used by the establishment; The following classes of persons are and the type of business (manufacturer not requested to register in accordance and/or packer). The information re- with this part 710 because the Commis- quested should be given separately for sioner has found that such registration each establishment as defined in is not justified: § 700.3(j) of this chapter. (a) Beauty shops, cosmetologists, re- tailers, pharmacies, and other persons [39 FR 10059, Mar. 15, 1974, as amended at 46 and organizations that compound cos- FR 38073, July 24, 1981; 54 FR 39640, Sept. 27, metic products at a single location and 1989] administer, dispense, or distribute § 710.5 Amendments to registration. them at retail from that location and who do not otherwise manufacture or Within 30 days after a change in any package cosmetic products at that lo- of the information contained on a sub- cation. mitted Form FD–2511, a new Form FD– (b) Physicians, hospitals, clinics, and 2511 should be submitted to amend the public health agencies. registration. This amendment is also (c) Persons who manufacture, pre- necessary when a registration is to be pare, compound, or process cosmetic canceled because an establishment has products solely for use in research, changed its name and no longer con- pilot plant production, teaching, or ducts business under the original chemical analysis, and who do not sell name. these products. § 710.6 Notification of registrant; cos- metic product establishment reg- PART 720—VOLUNTARY FILING OF istration number. COSMETIC PRODUCT INGRE- The Commissioner of Food and Drugs DIENT AND COSMETIC RAW MA- will provide the registrant with a vali- TERIAL COMPOSITION STATE- dated copy of Form FD–2511 as evi- MENTS dence of registration. This validated copy will be sent only to the location Sec. shown for the registering establish- 720.1 Who should file. ment. A permanent registration num- 720.2 Times for filing. 720.3 How and where to file. ber will be assigned to each cosmetic 720.4 Information requested about cosmetic product establishment registered in ac- products. cordance with the regulations in this 720.5 [Reserved] part. 720.6 Amendments to statement.
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720.7 Notification of person submitting cos- § 720.4 Information requested about metic product ingredient statement. cosmetic products. 720.8 Confidentiality of statements. (a) Form FDA–2512 requests informa- 720.9 Misbranding by reference to filing or to statement number. tion on: (1) The name and address, including AUTHORITY: 21 U.S.C. 321, 331, 361, 362, 371, post office ZIP code of the person 374. (manufacturer, packer, or distributor) SOURCE: 39 FR 10060, Mar. 15, 1974, unless designated on the label of the product. otherwise noted. (2) The name and address, including post office ZIP code, of the manufac- § 720.1 Who should file. turer or packer of the product if dif- Either the manufacturer, packer, or ferent from the person designated on the label of the product, when the man- distributor of a cosmetic product is re- ufacturer or packer submits the infor- quested to file Form FDA 2512 (‘‘Cos- mation requested under this paragraph. metic Product Ingredient Statement’’), (3) The brand name or names of the whether or not the cosmetic product cosmetic product. enters interstate commerce. This re- (4) The cosmetic product category or quest extends to any foreign manufac- categories. turer, packer, or distributor of a cos- (5) The ingredients in the product. metic product exported for sale in any (b) The person filing Form FDA–2512 State as defined in section 201(a)(1) of should: the Federal Food, Drug, and Cosmetic (1) Provide the information requested Act. No filing fee is required. in paragraph (a) of this section. (2) Have the form signed by an au- [57 FR 3129, Jan. 28, 1992] thorized individual. (3) Provide poison control centers § 720.2 Times for filing. with ingredient information and/or Within 180 days after forms are made adequate diagnostic and therapeutic available to the industry, Form FDA procedures to permit rapid evaluation 2512 should be filed for each cosmetic and treatment of accidental ingestion product being commercially distrib- or other accidental use of the cosmetic uted as of the effective date of this product. part. Form FDA 2512 should be filed (4) Provide ingredient information within 60 days after the beginning of (and, when requested, ingredient sam- commercial distribution of any product ples) to a licensed physician who, in not covered within the 180-day period. connection with the treatment of a pa- tient, requests assistance in deter- [57 FR 3129, Jan. 28, 1992] mining whether an ingredient in the cosmetic product is the cause of the § 720.3 How and where to file. problem for which the patient is being Forms FDA 2512 and FDA 2514 (‘‘Dis- treated. continuance of Commercial Distribu- (c) One or more of the following cos- tion of Cosmetic Product Formula- metic product categories should be tion’’) are obtainable on request from cited to indicate the product’s intended the Food and Drug Administration, De- use. partment of Health and Human Serv- (1) Baby products. (i) Baby shampoos. ices, Washington, DC 20204, or at any (ii) Lotions, oils, powders, and Food and Drug Administration district creams. (iii) Other baby products. office. The completed form should be (2) Bath preparations. (i) Bath oils, mailed or delivered to: Cosmetic Prod- tablets, and salts. uct Statement, Food and Drug Admin- (ii) Bubble baths. istration, Department of Health and (iii) Bath capsules. Human Services, Washington, DC 20204, (iv) Other bath preparations. according to the instructions provided (3) Eye makeup preparations. (i) Eye- with the forms. brow pencil. [57 FR 3129, Jan. 28, 1992] (ii) Eyeliner. (iii) Eye shadow.
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(iv) Eye lotion. (ii) Deodorants (underarm). (v) Eye makeup remover. (iii) Douches. (vi) Mascara. (iv) Feminine hygiene deodorants. (vii) Other eye makeup preparations. (v) Other personal cleanliness prod- (4) Fragrance preparations. (i) Co- ucts. lognes and toilet waters. (11) Shaving preparations. (i) (ii) Perfumes. Aftershave lotions. (iii) Powders (dusting and talcum) (ii) Beard softeners. (excluding aftershave talc). (iii) Men’s talcum. (iv) Sachets. (iv) Preshave lotions (all types). (v) Other fragrance preparations. (v) Shaving cream (aerosol, (5) Hair preparations (noncoloring). brushless, and lather). (i) Hair conditioners. (vi) Shaving soap (cakes, sticks, (ii) Hair sprays (aerosol fixatives). etc.). (iii) Hair straighteners. (vii) Other shaving preparation prod- (iv) Permanent waves. ucts. (v) Rinses (noncoloring). (12) Skin care preparations, (creams, lo- (vi) Shampoos (noncoloring). tions, powder, and sprays). (i) Cleansing (vii) Tonics, dressings, and other hair (cold creams, cleansing lotions, liquids, grooming aids. and pads). (viii) Wave sets. (ii) Depilatories. (ix) Other hair preparations. (iii) Face and neck (excluding shav- (6) Hair coloring preparations. (i) Hair ing preparations). dyes and colors (all types requiring (iv) Body and hand (excluding shav- caution statement and patch test). ing preparations). (ii) Hair tints. (v) Foot powders and sprays. (iii) Hair rinses (coloring). (vi) Moisturizing. (iv) Hair shampoos (coloring). (vii) Night. (v) Hair color sprays (aerosol). (viii) Paste masks (mud packs). (vi) Hair lighteners with color. (ix) Skin fresheners. (vii) Hair bleaches. (x) Other skin care preparations. (viii) Other hair coloring prepara- (13) Suntan preparations. (i) Suntan tions. gels, creams, and liquids. (7) Makeup preparations (not eye). (i) (ii) Indoor tanning preparations. Blushers (all types). (iii) Other suntan preparations. (ii) Face powders. (d) Ingredients in the product should (iii) Foundations. be listed as follows: (iv) Leg and body paints. (1) A list of each ingredient of the (v) Lipstick. cosmetic product in descending order (vi) Makeup bases. of predominance by weight (except that (vii) Rouges. the fragrance and/or flavor may be des- (viii) Makeup fixatives. ignated as such without naming each (ix) Other makeup preparations. individual ingredient when the manu- (8) Manicuring preparations. (i) facturer or supplier of the fragrance Basecoats and undercoats. and/or flavor refuses to disclose ingre- (ii) Cuticle softeners. dient data). (iii) Nail creams and lotions. (2) An ingredient should be listed by (iv) Nail extenders. the name adopted by the Food and (v) Nail polish and enamel. Drug Administration (FDA) for the in- (vi) Nail polish and enamel removers. gredient pursuant to § 701.3(c) of this (vii) Other manicuring preparations. chapter. (9) Oral hygiene products. (i) (3) In the absence of a name adopted Dentifrices (aerosol, liquid, pastes, and by FDA pursuant to § 701.3(c) of this powders). chapter, its common or usual name, if (ii) Mouthwashes and breath fresh- it has one, or its chemical or technical eners (liquids and sprays). name should be listed. (iii) Other oral hygiene products. (4) If an ingredient is a mixture, each (10) Personal cleanliness. (i) Bath ingredient of the mixture should be soaps and detergents. listed in accordance with paragraphs
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(d)(2) and (d)(3) of this section, unless commercial distribution becomes such mixture is a formulation volun- known to the person filing. tarily registered on Form FDA 2512, in (Information collection requirements in this which case such mixture should be section were approved by the Office of Man- identified as ‘‘fragrance,’’ ‘‘flavor,’’ agement and Budget (OMB) and assigned ‘‘fragrance and flavor’’ or ‘‘base formu- OMB control number 0910–0030) lation,’’ as appropriate, and by stating [57 FR 3130, Jan. 28, 1992] its FDA-assigned cosmetic product in- gredient statement number. § 720.7 Notification of person submit- (5) When the manufacturer or sup- ting cosmetic product ingredient plier of a fragrance and/or flavor re- statement. fuses to disclose ingredient data, the When Form FDA 2512 is received, fragrance and/or flavor should be listed FDA will either assign a permanent as such. The nonconfidential listing of cosmetic product ingredient statement the product name and/or trade name or number or a Food and Drug Adminis- name of the manufacturer or supplier tration (FDA) reference number in of each proprietary fragrance and/or those cases where a permanent number flavor mixture is optional. cannot be assigned. Receipt of the form (e) A separate Form FDA–2512 should will be acknowledged by sending the be filed for each different formulation individual signing the statement an ap- of a cosmetic product. However, except propriate notice bearing either the for the hair coloring preparations list- FDA reference number or the perma- ed in paragraph (c)(6) of this section for nent cosmetic product ingredient which a statement for each shade of statement number. If the person sub- such product is required, a single Form mitting Form FDA 2512 has not com- FDA–2512 may be filed for two or more plied with §§ 720.4 (b)(1) and (b)(2), the shades of a cosmetic product where person will be notified as to the man- only the amounts of the color additive ner in which the statement is incom- ingredient used are varied or in the plete. case of flavors and fragrances where [57 FR 3130, Jan. 28, 1992] only the amounts of the flavors and fragrances used are varied. § 720.8 Confidentiality of statements. (Information collection requirements in this (a) Data and information contained section were approved by the Office of Man- in, attached to, or included with Forms agement and Budget (OMB) and assigned FDA 2512 and FDA 2514, and amend- OMB control number 0910–0030) ments thereto are submitted volun- [39 FR 10060, Mar. 15, 1974, as amended at 46 tarily to the Food and Drug Adminis- FR 38073, July 24, 1981; 57 FR 3129, Jan. 28, tration (FDA). Any request for con- 1992] fidentiality of a cosmetic ingredient submitted with such forms or sepa- § 720.5 [Reserved] rately will be handled in accordance with the procedure set forth in this § 720.6 Amendments to statement. section and in § 20.44 of this chapter. Changes in the information requested The request for confidentiality will under §§ 720.4 (a)(3) and (a)(5) on the in- also be subject to the provisions of gredients or brand name of a cosmetic § 20.111 of this chapter, as well as to the product should be submitted by filing exemptions in subpart D of part 20 of an amended Form FDA 2512 within 60 this chapter and to the limitations on days after the product is entered into exemption in subpart E of part 20 of commercial distribution. Other this chapter. changes do not justify immediate (b) Any request for confidentiality of amendment, but should be shown by the identity of a cosmetic ingredient filing an amended Form FDA 2512 with- should contain a full statement, in a in a year after such changes. Notice of well-organized format, of the factual discontinuance of commercial distribu- and legal grounds for that request, in- tion of a cosmetic product formulation cluding all data and other information should be submitted by Form FDA 2514 on which the petitioner relies, as well within 180 days after discontinuance of as representative information known
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to the petitioner that is unfavorable to draw the records for which FDA has the petitioner’s position. The state- tentatively denied a request for con- ment of the factual grounds should in- fidentiality or may submit, within 60 clude, but should not be limited to, sci- days from the date of receipt of the entific or technical data, reports, tests, written notice of the tentative denial, and other relevant information ad- additional relevant information and ar- dressing the following factors that guments and request that the agency FDA will consider in determining reconsider its decision in light of both whether the identity of an ingredient the additional material and the infor- qualifies as a trade secret: mation that it originally submitted. (1) The extent to which the identity of the ingredient is known outside peti- (f) If the petitioner submits new data tioner’s business; in response to FDA’s tentative denial (2) The extent to which the identity of trade secret status, the agency will of the ingredient is known by employ- consider that material together with ees and others involved in petitioner’s the information that was submitted business; initially before making its final deter- (3) The extent of measures taken by mination. the petitioner to guard the secrecy of (g) A final determination that an in- the information; gredient is not a trade secret within (4) The value of the information the meaning of § 20.61 of this chapter about the identity of the claimed trade constitutes final agency action that is secret ingredient to the petitioner and subject to judicial review under 5 to its competitors; U.S.C. Chapter 7. If suit is brought (5) The amount of effort or money ex- within 30 calendar days after such a de- pended by petitioner in developing the termination, FDA will not disclose the ingredient; and records involved or require that the (6) The ease or difficulty with which disputed ingredient or ingredients be the identity of the ingredient could be properly acquired or duplicated by oth- disclosed in labeling until the matter ers. is finally determined in the courts. If (c) The request for confidentiality suit is not brought within 30 calendar should also be accompanied by a state- days after a final determination that ment that the identity of the ingre- an ingredient is not a trade secret dient for which confidentiality is re- within the meaning of 21 CFR 20.61, and quested has not previously been pub- the petitioner does not withdraw the lished or disclosed to anyone other records for which a request for con- than as provided in § 20.81(a) of this fidentiality has been denied, the chapter. records involved will be made a part of (d) FDA will return to the petitioner FDA files and will be available for pub- any request for confidentiality that lic disclosure upon request. contains insufficient data to permit a review of the merits of the request. [51 FR 11444, Apr. 3, 1986, as amended at 57 FDA will also advise the petitioner FR 3130, Jan. 28, 1992] about the additional information that § 720.9 Misbranding by reference to fil- is necessary to enable the agency to ing or to statement number. proceed with its review of the request. (e) If, after receiving all of the data The filing of Form FDA 2512 or as- that are necessary to make a deter- signment of a number to the statement mination about whether the identity of does not in any way denote approval by an ingredient is a trade secret, FDA the Food and Drug Administration of tentatively decides to deny the re- the firm or the product. Any represen- quest, the agency will inform the per- tation in labeling or advertising that son requesting trade secrecy of its ten- creates an impression of official ap- tative determination in writing. FDA proval because of such filing or such will set forth the grounds upon which number will be considered misleading. it relied in making this tentative de- termination. The petitioner may with- [57 FR 3130, Jan. 28, 1992]
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