Document e1xzZvZwzMN1DeDYxZO29q55M

* i **>V, federal regigtek Vol. 37, No. 7H Tuenday, April 11, 1972 Paf.jes 7151-71 Co-S/r/ / 'c. /?<<?'S'?a r/c ^ 5UBCHAPTE* D--COSMETICS PART 170--VOLUNTARY REGISTRA TION OF COSMETIC PRODUa ES TABLISHMENTS PART 172--VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT AND COSMETIC RAW MATERIAL COMPOSITION STATEMENTS In the matter of Issuing regulations establishing a procedure for (1) the vol untary registration of cosmetic product establishments and (2) the voluntary fil ing of cosmetic product Ingredient statements: A notice regarding these regulations which were based on two petitions filed by the Cosmetic. Toiletry, and Fragrance Association, Inc, (CTFA), 1625 I Street NW, Washington, DC 20006, was pub lished In the Federal Register of August 26, 1971 (36 F.R. 16934), In the 65(Ke~noTTc<rtHe Commissioner of Food and Drugs proposed a parenthetical statement which, If the regulations were adopted, would be inserted to identify certain cosmetic products that are also regarded as drugs by the Food and Drug Administration. Interested persons were Invited to submit comments on the pro posal within a 30-day period wlilch end ed September 25, 1971, Twenty-two com ments were received. With regard to the promulgation of these regulations In general, a member of Congress urged that tho registration and filing of Ingredient statements by pro ducer's of cosmetics bo mandatory, that foreign producers of cosmetics be sub jected to the regulations, and that in gredient labeling of cosmetic products be required. Two other comments chal lenged the legality of establishing volun tary regulations under section 701(a) of tho Federal Food, Drug, and Cosmetic Act apd urged that the regulations is sued be mandatory. These two comments Included legal arguments to support claims that It Is extra legal to provide that data submitted voluntarily by firms filing cosmetic product Ingredient state ments be kept confidential by FDA: that authority now exists to require manda tory registration of cosmetic product es tablishments, filing ot cosmetic ingre dient statements, label declaration of in gredients on cosmetic products, and label declaration of any registration number issued by the Commissioner; and that authority now exists to pro vide that any cosmetic product that did not have an FDA-issued registration number on the label would be deemed to be misbranded. The Commissioner has considered these comments and concludes that un der section 701(a) of the act he is au thorized to accept the voluntary regis tration of Cosmetic product establish ments and the voluntary filing of cos metic product Ingredient statements and cosmetic raw material composition state ments as set forth in the regulations es tablished below. He also agrees that for eign producers should be included In this voluntary registration. Ho concludes however that promulgation of a manda tory regulation could result in lengthy litigation that would seriously delay FDA from obtaining the type of information expected as result of this promulgation. If it is determined that the information obtained through the procedure estab lished In these regulations does not ade quately contribute to the efficient en forcement of tho act, additional steps will be taken to promulgate mandatory regulations. The Commissioner further concludes that mandatory Ingredient labeling goes beyond the scope of the proposal and cannot be implemented by these regulations. Comments recommending label decla rations of Ingredients for cosmetic products are considered by the Com missioner to be meritorious. The Com missioner recognizes that regulations re quiring cosmetic product ingredient dis closure on the labels of such products will prevent tho deception of consumers and facilitate value comparisons. This Issue was not a part of the CTFA peti tions. Consideration Is being given to publishing a proposal under the Fed eral Fair Packaging and Labeling Act, section 6(c)(3), 16 TJ.S.C. 1454(c)(3), for labeling of sensitizing ingredients. ASI 00003083 A derm&tologtft commented that the proposed regulations were a step In the right direction but that they did not go far enough, particularly in the provi sion for providing coded samples to physicians treating persons suffering from allergic reaction. He urged estab lishment of a "Register" that would list all ingredients of all cosmetic products used in the United States and would be made available to every practicing der matologist The Commissioner concludes that a ``Register" of cosmetic ingredients goes beyond the scope of the proposal and cannot be Implemented by these regulations. The Commissioner considers that promulgation of labeling require ments for cosmetic Ingredients will sub stantially satisfy the need of dermatol ogists for this type of data. One comment from a professor at a school of medicine urged that feminine hygiene deodorants be considered drags as are feminine douche products. This request waa also included in the com ment submitted by the member of Con gress. Twelve of those commenting op posed the Commissioner's- proposed parenthetical statement. These com ments have been fully considered. The Commissioner concludes that the parenthetical statement Is not a neces sary element of this voluntary regula tion. In lieu of this statement, the pro posed regulations have been changed to Indicate that a cosmetic product which Is also a drug Is subject to the drug re quirements of the Federal Food, Drug, and Cosmetic Act. In his proposed parenthetical state ment. the Commissioner cited cosmetic product categories which are also re garded as drugs because of their intended use, He would like to point out that the failure to cite feminine hygiene deodor ants as an example should not be con strued to Indicate that such products may not also be considered drugs under appropriate circumstances. One comment concerned the possible theft of Ingredient information and urged that funds commensurate with the value of the formulations submitted to FDA ,be set aside to reimburse the owner of a 'stolen cosmetic formulation. The Com missioner concludes that creation of a special fund goes beyond the scope of the proposal and cannot be Implemented by these regulations. A public Interest group objected to the all-inclusive acope of the petitioner's proposed provisions concerning confiden tiality of statements submitted pursuant to Part 172. The commissioner concludes that these objections are valid, and the regulations have been changed so that such provisions are consistent with the mandate of section (3) (e> (4) of the Ad ministrative-Procedures Act (5 U.S.C. 552(b)(4)). Fourteen associations or firms that are either Involved In or closely allied to the cosmetic product industry favored the regulations proposed by the petitioner. However, some of these suggested amend atory language that would clarify and improve the procedure for obtaining com positional Information regarding proprie tary ingredients used in finished cos metics. Accordingly, on the basis of the com ments received and the Commissioner's conclusions, the proposed regulations arc being promulgated with the following changes: 1. For clarity, the titles of Ports 170 and 172 have been changed and new definitions are added to {{171.1 and 172.1. 2. Changes have been made through out Parts 170 and 172 in order to Include foreign cosmetic producers In these vol untary registration procedures. 3. A sentence has been added to i 172.1 (b) to point out that a cosmetic product which is also a drug Is subject to the drug provisions of the act. 4. Clarifying changes have been made In 1172.5(a)(1) and (2), (b)(5), (d)(2) and (3), and (c>, and a new subdivision has been added to paragraph (d> (1). 5. A new { 172.6 Information requested about cosmetic raw material has been added, and proposed S9 172.6-172.9 hnvo been redesignated as f { 172.7-172.10. 6. To further implement new i 172,6, appropriate amendments have been made in Si 172.2. 172.3, 172.4, 172.7 and 172.0. 7. The section heading of S 172.8 has been changed and the section is revised to clarify the procedure for acknowledg ing the receipt of statements, advising persons filing Incomplete statements, and issuing statement numbers to persons filing complete statements. 8. Section 172.9 Is revised to clarify tho conditions under which trade secrets, and other privileged and confidential com mercial information will be held In con fidence consistent with the provisions of section 3(e) (4) of the Administrative Procedures Act as amended. 8. A new paragraph <b> has been added to 5 172.10 to explain how the Food and Drug Administration Cosmetic Raw Material Composition Statement Number may be used. Therefore, pursuant to provisions of the Federal Food, Drug, ahd Cosmetic Act (secs. C01. 602. 701(a), 704, 52 Stat. 1054 as amended. 1055,1057 as amended: 21 U.S.C. 301. 362, 371(a), 374) and under authority delegated to the Commissioner (21 CFR 2.120) It is ordered. That 21 CFR Chapter I be editorially amended by redesignating the present Subchapters D and E as Subchapters E and F, respec tively, and that a new Subchaptor D-- Cosmetics be established consisting at this time of two new Parts 170 and 172, as follows: Sec. 170.1 170.3 170.3 170.4 170 S 170.0 170.7 170.3 170-9 170.51 Definitions. Who should register. Time Tor regluUmUon. How and whore to register, In formation requested. Amendments to registration. Notification of registrant: conmetle products establishment registra tion number. Inspection of registrations. Mlsbrundlng by reference to registra tion or to registration number, Exemptions, Authoiutt: The provisions of this Part 170 Issued under secs. 601. 602. 701(a), 704, 63 Stat. 1054, aa amended, 1055. 1057, aa amended; 31 US.C. 301,302, 371(a). 374. 170.1 Definition*. (a) Tho term "cosmetic product" means a finished cosmetic the manulacture of which rids been completed, (b) "Establishment" means a place of business where cosmetic products arc manufactured or packaged. (c) The term "manufacture" of a cos metic product means the making of any cosmetic product by chemical, physical, biological, or other procedures. Including manipulation, sampling, testing, or con trol procedures applied to the product, (d) The term ''packaging'* of a cos metic product means filling or labeling the product container. Including chang ing the immediate container or label (but excluding changing other labeling) at any point in the distribution of the cos metic product from the original place or manufacture to the person who makes final delivery or sale to the ultimate consumer. (e) The term "all business trading names used by the establishment" means any name which is used on a cosmetic product label and owned by the cosmetic product manufacturer or packer, but is different from the principal name under which the cosmetic product manufac turer or packer is registered. , (f) The term "act" means the Federal Food, Drug, and Cosmetic Act. (g) The definitions and Interpreta tions contained in sections 201 and 602 of the Federal Food. Drag, and Cosmetic Act shall be applicable to such terms when used In the regulations in tins part. 170.2 Who nlioulil register. The owner or operator of a cosmetic product establishment which Is not ex empt under i 170.51 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. 170.3 Time for regiMrntiim. The owner or operator of an establish ment entering Into the manufacture or packaging of a cosmetic product should register his establishment within 30 days after the operation begins. 170.1 How anil where m register. FD Form 2511 ("Registration of Cos metic Product Establishment") is ob tainable on request from the Food and Drug Administration. Department of Health, Education, and Welfare, Wash ington, D.C. 20204, or at any Food and Drug Administration district office. Tho completed form should be mailed to Cos metic Product Establishment Registra tion. Food and Drui: Administration. ASI 00003084 Department of Health, Education, and (c) Persons who manufacture, pre (i) The definitions and Interpretations Welfare. Washington, D.C. 20204, 8 170S Information reqne*led. pare, compound, or process cosmetic contained In sections 201, 601, and C02 products solely for use In research, pilot of the net shall be applicable to such plant production, teaching, or chomtonl terms when used In the regulations in FD Form 2511 requests Information analysis, and who do not sell these prod tliis part. on the name and address of the cosmetic product establishment, including post ucts. (d) Carriers, by reason of their re 172,2 lilio ^imilii file. office ZIP code; all business trading ceipt, carnage, holding, or delivery of (a) Either the manufacturer, packer, names used by the establishment: the kind of ownership or operation (e.g., In dividually owned, partnership, or cor poration) ; and the type of business (manufacturer, packer, and/or distribu tor). The Information requested should be given separately for each establish ment as defined In S 170.1(b). cosmetic products in the usual course of business. Sec. 172.1 172 2 172 3 172.4 172.6 Definitions. Who aholild llln. TimTM for filing. How and whom u> file. Information requested metic products. about cos or distributor of a cosmetic product is re quested to file FD Form 2512 ("Cosmetic Product Ingredient Statement") wheth er or not the cosmetic product enters interstate commerce. Tliis request ex tends 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 ihe 170,6 Amendments to rcgitilrntion. 173.5 Information requested about cos act. No filing fee is required. Within 30 days after, a change in any of the Information contained on a sub mitted FD Form 2511, a new FD Form 172.7 172 8 metic raw materials. Amendments to statement. Notification of person submitting coomotto product lngrcdiont state (b) It is requested that FD Form 2513 ("Cosmetic Raw Material Composition Statement") be filed by cither the manu 3511 should be submitted to amend the ment cosmetic raw material com facturer or supplier of a cosmetic raw- registration. This amendment Is also position statement. material that Is a proprietary ingredient, necessary when a registration la, to be 172.0 Confidentiality of statements. or whose precise composition Is not- canceled because an establishment has 172.10 Misbranding by reference to filing known to the cosmetic manufacturer, changed Its name and no longer con or to etutamont number. packer, or distributor receiving the in ducts business under the original name. authority: Tho provisions of this Port gredient whether or not the raw ma 170.7 Notification of registrant; ci- melic product establishment registra- lion number. The Commissioner of Food and Drugs will provide the registrant with a vali dated copy of FD Form 3611 as evidence 172 Issued under secs. 601, 602, 701(a), 704, 62 Slat. 1064, an amended, 1066, 1067, an umomlcd; 21 VB.C. 301, 302. 371(a), 371. 172.1 Definition*. (a) The term "commercial distribu tion'' of a cosmetic product means an terial enters into interstate commerce. This request extends to any foreign man ufacturer or supplier of a cosmetic raw material that Is exported for such use in any State as defined In section 201 (a1 (1) of the act. No filing fee Is required. of registration. This validated copy will nual gross sales in excess of $1,000 for be sent only to the location shown for that product. the registering establishment. A perma (b) The term "cosmetic product" nent registration number will be as signed to each cosmetic product estab lishment registered In accordance with the regulations In this part. means a finished cosmetic the manufac ture of which has been completed. Any cosmetic product which is also a drug or device or component thereof Is also (subject to tiie requirements of Chapter S 170.8 Inspection of registrations. IV of the act. A copy of the FD Form 2511 filed by (c) Tho term "flavor" means any nat- the registrant will be available for In . ural, or synthetic substance or substances spection at the Food and Drug Admin used solely to impart a taste to a cos istration, Department of Health, Educa metic product. tion. and Welfare, Washington, D.C. (d) The term "fragrance" means any 30206. natural or synthetic substance or sub 172,3 Time* for filing. (a) Within 180 days after forms are made available to the Industry, FD Form 2512 should be filed for each cosmetic product being commercially distributed as of the effective date of this part. FD Form 2512 should be filed within 60 days after the beginning of commercial dis tribution of any product not covered within the 180-day period. (b) FD Form 2513 should be filed, pursuant to S 172.2(b). by a cosmetic raw material manufacturer or supplier for each cosmetic raw material. 9 170.9 Misbranding by reference to reg- iatratlon or to registration number. Registration of a cosmetic product es tablishment or assignment of a registra tion number does not In any way denote approval of the Ann or its products by the Food and Drug >dminlstratlon. Any representation In labeling or advertis ing that creates'an Impression of official approval because of registration or pos session of a registration number will be considered misleading. g 170.51 Exemption*. Hie following classes of persons are not requested to register in accordance with this Purl 170 because the commis sioner has found that such registration Is not Justified; stances used solely to Impart an odor to 172.4 How anil where In file. a cosmetic product. FT) Form 2512 and FD Form 2513 and (c) The term "Ingredient" means any FD Form 2514 ("Discontinuance of Com single chemical entity or mixture used as mercial Distribution of Cosmetic Product a component In the manufacture ol a or Cosmetic Raw Material") arc obtain cosmetic product. able on request from the Food and Drug (f) The term "proprietary Ingredient" Administration, Department of Health, means any cosmetic product ingredient Education, and Welfare, Washington. whose name, composition, or manufac D.C. 20204, or at any Food and Drur turing process is protected from com Administration district office. The com petition by secrecy, patent, or copyiiRht. (g) Tho term "chemical description" means a concise definition of the chemi cal composition using standard chemical pleted form should be mailed or de livered to: Cosmetic Product Statement, Food and Drug Administration, Depart ment of Health. Education, and Welfare. nomenclature so that the chemical Washington, D.C. 20204, according to the structure or structures of the compo nents of the Ingredient would be clear instructions provided with the forms. to a practicing chemist. When the com- ' 172.5 Information requested iiltoiit , position cannot be described chemically, ' eoMineiie products, ' the substance shall be described in terms (it) FD Form 2512 requests informa (a) Beauty shops, cosmetologists, re of its source and processing. tion on: tailers, pharmacies, and other persons (hi The term "cosmetic raw material" (1) The nnme and address, including and organizations that compound cos means any Ingredient, Including un in post office ZIP code, of the person (man metic products at a single location and gredient that is a mixture, wliich is used ufacturer, packer, or distributor' desig administer, dispense, or distribute them in the manufacture of a cosmetic prod nated on the label of the product. at retail from that location and who do uct for commercial distribution and is (2 > The name and address. Including not otherwise manufacture or package supplied to a cosmetic product manufac post office ZIP code, of the manufacturer cosmetic products at that location. turer, packer, or distributor by a cos or packer of the product if different from fb) Physicians, hospitals, clinics, nnd metic raw nuilerlul manufacturer or the person designated on the label of tho P'lbllc health agencies. supplier. product, when the manufacturer or ASI 00003085 packer submit# the Information re quested 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 FD Form 2512 should: (1) Provide the Information requested In paragraph (a) of this section. (2) Have the form signed by an au thorized individual. (3) Provide poison control centers with Ingredient Information and/or adequate diagnostic and therapeutic procedures to perihS rapid evaluation and treatment of accidental Ingestion or other acci dental use of the cosmetic product. (4) Provide ingredient Information (and, when requested, Ingredient sam ples) to a licensed physician who, In connection with the treatment of a pa tient, requests assistance in dctcnftinlng whether an Ingredient In the cosmetic product Is the cause of the problem for which the patient is being treated. (5) Request that an FD Form 2513 be filed pursuant to [ 172.6(b) by the manu facturer or supplier of any proprietary Ingredient (Including mixtures) or of any other cosmetic raw material which is used as an ingredient and has not as yet been assigned a cosmetic raw material composition statement number. (c) One or more of the following cos metic product categories should be cited to Indicate the product's Ihienqea Use. - (1) Baby products. (1) Baby shampoos, (il) Lotions, oils, powders, and creams. (Ill) Other baby products. (2) Bath preparations. <i) Bath oils, tablets, and salts. (11) Bubble baths. (ill) Bath capsules. (lv) Other bath preparations. (3) Eye makeup preparations, (i) Eye brow pencil. (II) Eyeliner. (III) Eye Bhadow. (iv) Eye lotion. ' (v) Eye makeup remover. (vl) Mascara. (vll) other eye makeup preparations. (4) Fragrance preparations, (i) Co lognes and toilet waters. (II) Perfumes. (III) Powders (dusting and talcum) (excluding aftershave talc). (iv) Bachete. (v) Other fragrance preparations. (5) Hair preparations (noncoloring). (1) Hair conditioners. (II) Hair sprays (aerosol fixatives). (III) Hair straighteners. (iv) Permanent waves. (v) Rinses (noncoloring). (vi) Shampoos (noncoioring). (Vll) Tonloe, dressings, and oilier hair grooming aids. (vlll) Wave sets. <lx) Other hair preparations, (6) Hair coloring reparations. (1) Hair dyes and colors (all types requiring caution statement and patch test). <ll) Hair tints. (Ill) Hair rinses (coloring). (iv) Hair shampoos (coloring). (v) Hair color sprays (aerosol). (vl) Hair 11ghteners with color. (vii) Hair bleaches. (vill) Other hair coloring prepara tions, , (7) Makeup preparations (not eye'). (1) Blushers (all types). (ii) Face powders. (lit) Foundations. (iv) Leg and body paints. (v) Lipstick. (vi) Makeup bases. (vii) Rouges. (viii) Makeup fixatives. (ix) Other makeup preparations. (8) Manicuring prcimrations. (1) Basecoats and undercoats. (li) Cuticle softeners. (iii) Nall creams and lotions. (iv) Noil extenders. (v) Nail polish and enamel. (vl) Nail polish and enamel removers. (vll) Other manicuring preparations, (9) Oral hygiene products. (1) Denti frices (aerosol, liquid, pastes, and pow ders). (11) Mouthwashes and breath fresh eners (liquids and sprays). (i il) Other oral hygiene products. (10) Personal cleanliness. (1) Bath soaps and detergents. (11) Deodorants (underarm). (Ill* Douches. (iv) Feminine hygiene deodorants. (v) Other personal cleanliness prod ucts. (ID Shaving preparations. (1) After shave lotions. (11) Beard softeners. (111) Men's talcum. (lv Preshave lotions (all types). (v) Shaving cream (aerosol, brushless, and lather). (vi) Shaving soap (cakes, sticks, etc.). (vii) Other shaving preparation prod ucts. (12) Skin care reparations (creams. lotions, powder, and srays). (1) Cleans ing (cold creams, cleansing lotions, li quids, and pads). (11) Depilatories. (ill) Face, body, and hand (excluding shaving preparations). (lv) Foot powders and sprays. (v) Hormone. (vl) Moisturizing. (vll) Night. (vlll) Paste marks (mud packs). (lx) Skin lighteners. (x) Skin fresheners. (xl) Wrinkle smoothing (removers), (xii) Other skin care preparations. (13) Suntan and sunscreen prepara tions. (1) Suntan gels, creams, and li quids. (ii) Indoor tanning preparations, (lil) Other suntan preparations. (d> Ingredients in the product should be indicated 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 des ignated as such without naming each in dividual Ingredient when the manufac turer or supplier of the fragrance and-' or flavor refuses to disclose ingredient data) should be accompanied by a letter designating the percentage of the in gredient added, as follows: (i) The letter A represents over 50 per cent. Ui) The IctLer B represents over 25 percent to 60 percent. (Iii) The letter C represents over 10 percent to 25 percent. (lv) The letter D represents over 5 percent to 10 percent. (v) The letter E represents over 1 per cent to 5 percent. (vi) The letter F represents over o.l percent to 1 percent. (vii) The letter G represents 0.1 per* cent or less. / (vill) The letter H represents 0/per- cent. (The letter H Is to be used .Only to Indicate that a particular coior'additTve is absent In certain shades of a product as desenuca in tne instructions lfTTD Form 2512.) (ii) An ingredient, Including an ingre dient that is a mixture, should be listed by its common or usual name. If it luvs one; or by its chemical name (except proprietary Ingredients); or by its trade name and the name of manufacturer or supplier. If such ingredient complies wit!) a published standard (e.g., "The United States Pharmacopeia." "National For mulary," "Food Chemicals Codex." "CTFA Standards--Specifications," etc.) list only the common, usual, or chemical name found In the published standard and the name of the standard used, if a cosmetic raw material composition statement number ha: already been as signed to on ingredient, list only the number and the name tinder which the Ingredient was registered. (3) When the manufacturer or sup plier of a fragrance and/or flavor refuses to disclose Ingredient data, the fragrance and/or flavor should be listed as such with the product name and/or trade name or number and the name of the maimtucturcr or supplier of each pro prietary mixture that Is included. (o> A separate FD Form 2512 should bo 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 FD Form 2512 may be filed for two or more shades of a cosmetic product where only the amounts of the color additive ingredient used arc varied or in the ease of flavors and fragrances where only the amounts of the flavors and lragrances used are varied. 172.6 liifornmijon roqii<**ir! about n^iiiolip raw niiitfriiiis. (a) FD Form 2513 requests informa tion on; (1) The name and address, including post ofllre ZIP code, of the manufacturer or supplier of the cosmetic raw material. (2) The trade name or names of the cosmetic raw material. (3> Tile Identity of the ingredient In a cosmetic raw material or of the ingredi- ASI 00003086 ents It the cosmetic raw material is a mixture. (b) The person filing FD Form 2513 should: (1) Provide the Information requested in paragraph (a) of this section for each cosmetic raw material which is to be an ingredient in a cosmetic product offered for commercial distribution, whenever it is a proprietary ingredient (except that the fragrance and/or flavor may be designated as such without nam ing each individual ingredient when the manufacturer or supplier of the fra grance and/or flavor refuses to disclose Ingredient data) or an ingredient whose precise composition is not known to the cosmetic product manufacturer, packer, or distributor using it. (2) Have It signed by an authorised Individual. (c) Information on the composition of cosmetic raw material should be shown as follows: (1) A cosmetic raw material or an In gredient in a cosmetic raw material, in cluding mixtures, should be listed by its common or usual name, if it has one; or Its chemical name: or its chemical de scription. If this information is not avail able. list the trade name and supplier and request the manufacturer or sup plier to file an FD Form 2513. if such cosmetic raw material or Ingredient com plies with a published standard fo.g. "The United States Pharmacopeia," "National Formulary," "Food Chemicals Codex," "CTFA Standards--Specifica tions," etc.) list only the common, usual, or chemical name in the published stand ard and the name of the standard used. If a coemetic raw material composition statement number has already been as signed to an Ingredient, list only the number and the name under which the ingredient was registered. (2) A cosmetic raw material that is a prepared mixture of ingredients should have each ingredient listed in descending order of predominance by weight (except that fragrance and/or flavor, if present, may be designated as such without nam ing each individual ingredient when the manufacturer or supplier of the fra grance and/or flavor refuses to disclose ingredient data) with a letter designat ing the percentage of the ingredient added as described under 5172.5(d) (1). (3) When the manufacturer or sup plier of a fragrance and/or flavor refuses to disclose ingredient data, the fragrance and/or flavor used in a cosmetic raw material should be listed as such with the product name and/or trade name or number and the name of the manufac turer or supplier. (4) Ingredients In a prepared mixture of color additives, with or without dilu ents, that are used as cosmetic raw mate rials should be listed as described In sub paragraphs (1) and (2) of this para graph, using the approved FDA name of tile color additive and/or diluent as listed in Part 8 or this chapter. fd) The information requested should bo given separately for each cosmetic raw material. 172.7 Amrndmcitls to Blaleim'tlt. (a) Changes in the information re quested under 172.5(a) (3) and (5) on the ingredients or brand name of a cos metic product should be submitted by filing an amended FD Form 2512. with in 00 days after the product is entered into commercial distribution. Other changes do not justify immediate amend ment, but should be shown by filing an amended FD Form 2512 within a year after such changes. Notice of discontinu ance of commercial distribution of a cosmetic product should be submitted by Fl) Form 2514 within 180 days after dis continuance of commercial distribution becomes known to the person filing. (b) Changes in the information requested under s I72.lu a) (3) ana' (3* oil the name or ingredients of a cosmetic raw material should be submitted by fil ing an amended FD Form 2513 on or be fore llio time the cosmetic raw material is suppiied to a cosmetic product manu facturer. packer, or distributor for use in a product for commercial distribution. Tho manufacturer, packer, or distributor should also be Informed about any change in the name of a cosmetic raw material so he can send an amended FD Form 2512 as requested in paragraph (a) of this section. Other changes should be indicated by Ailing an amended FD Form 2513 within a year after these changes arc made. Notice of dlsronllnuanco of commercial distribution of a cos metic raw material should be siihmlttcd by FD Form 2514 within 180 days after discontinuance of commercial distribu tion becomes known to the person filing. f) 172,8 Notification of person submit ting eonmetir product ingredient Intement and cosmetic row niiUeriiil composition stniemrnl. When FD Forms 2512 and 2513 are received, the Commissioner of Food and Drugs will either assign a permanent cosmetic statement number or an FDA reference number in those .cases where a jiermanent number cannot be assigned. Receipt of tlie forms will be acknowl edged oy sending tne individual signing the statement an appropriate notice healing el tiler tho FDA reference num ber or the permanent cosmetic state ment number, it the person submitting r'b form 2512 has not compiled with 5 172.5(b) (1) and (2) or the person sub mitting FD Forms 2513 has not compiled with { 172.6<b), lie will be notified as to the manner in which his statemcnl isliD complete. 172.0 Guifidciiliidity of violcnicols. (a) Each item of Information contnined In, attached to, or included with FD Forms 2512, 2513, 2514, and amend ments thereto and constituting n trade secret or other privileged and eoiilldentlal. commercial information exempt from disclosure to tile public must be clearly marked as confidential Fach item of information so marked must bo accompanied by a statement setting forth adequate grounds to Justify its confidentiality. If the Food and Drug Administration concludes that nn item so marked is not exempt from disclosure to the public, the person submitting the information will be informed and will be given an opportunity to appeal that decision to tho Assistant Commissioner for Public Affairs, whose decision on the matter will be final. (hi Data and information otherwise exempt from public disclosure may lie revealed in administrative or court en forcement proceedings where the data or information are relevant.. Any such use will lie in a manner that reduces public disclosure to the minimum nercssai.v un der the circumstances. id Data and information otherwise exempt from public disclosure may he disclosed to consultants, advisory com mittees, nnd other persons who are spe cial government employees. Such per sons are thereafter subject to the same restrictions with respect to disclosure ns any Food and Drug Administration em ployee. 172.10 Mi-!r;nubMg liy reference to filing or Io fclnleinenl vuioiher, (a) The filing of an FD Form 2512 or 25J3 or assignment of a number to the statement does not In any way denote approval by the Food and Ding Admin istration of the firm or the product. Any representation In labeling or advertising that creates an impression of olTicial ap proval because of such filing or such number will be considered misleading, except as set forth 111 paragraph <b> of this section. (b) The manufacturer or supplier of a cosmetic raw material that lias been assigned a Food and Drug Administra tion Cosmetic Raw Material Composi tion statement number (FDA CRMCS No.) pursuant to S 172.8 may use this number without violating the misbrand ing provision of this section under the following conditions: (1) The FDA CRMCS No. is placed on the label of the container which is used to ship or transport the cosmetic raw material to a manufacturing estab lishment if the principal display panel of the label also contains the following disclaimer: P'The FDA Cosmetic Raw Material Composition Statement number Is assigned for raw material identifica tion purposes only and does not. in any way denote approval of the Arm or the raw material by the Food nnd Drug Ad ministration^ The disclaimer phrase shall be prominently placed thereon with such ronspicuousncss (ns compared with other words, statements, designs, or de vices' ns to render it likely to be read and understood by the ordinary individual. (2) The FDA CRMCS No. is used ill; cosmetic raw material trade literature, j 'catalogue citations, and correspondence if the disclaimer specified in subpara graph (1) of this paragraph is made mi tiie same page that the FDA CRMCS No , appears. Effective, date. Part 170 shall become effective 30 days after notice that IT) Form 2511 Is available for distribution, nnd Part 172 ............... . ASI 00003087 days after notice that FD Forms 2512, 2613, and 2514 are available for distribu tion. Notice of the date each of the forms will be available will be published iriTtie Federal Register. It Is anticipated that FD Form 2511 will be available on a date to be announced during April 1972 and that FD Forms 2612, 2513, oni 2514 will be available on a date to be announced In May 1972. In the meantime, those de siring any of these forms may submit requests to the Food and Drug Admin istration as set forth in S! 170.4 and 172.14 (21 CFR 170.4 nnd 172.4). Dated: March 31, 1972. Charles C. Edwards, Commissioner of Food and Dm -- |FR Doc.72-S208 Filed 4-0-72;8:45 n