Color additive petitions (21 CFR 71.1-71.37)

394 21 CFR Ch. I (4–1–16 Edition) § 70.51 to people must satisfy the require ments of subpart E of part 500 of this chapter. [42 FR 15636, Mar. 22, 1977, as amended at 43 FR 22675, May 26, 1978; 52 FR 49586, Dec. 31, 1987] § 70.51 Advisory committee on the ap plicability of the anticancer clause. All requests for and procedures gov erning any advisory committee on the anticancer clause shall be subject to the provisions of part 14 of this chap ter, and particularly subpart H of that part. § 70.55 Request for scientific studies. The Commissioner will consider re quests by any interested person who desires the Food and Drug Administra tion to conduct scientific studies to support a petition for a regulation for a color additive. If favorably acted upon, such studies will be limited to pharmacological investigations, stud ies of the chemical and physical struc ture of the color additive, and methods of analysis of the pure color additive (including impurities) and its identi fication and determination in foods, drugs, or cosmetics, as the case may be. All requests for such studies shall be accompanied by the fee prescribed in § 70.19. PART 71—COLOR ADDITIVE PETITIONS Subpart A—General Provisions Sec. 71.1 Petitions. 71.2 Notice of filing of petition. 71.4 Samples; additional information. 71.6 Extension of time for studying peti tions; substantive amendments; with drawal of petitions without prejudice. 71.15 Confidentiality of data and informa tion in color additive petitions. 71.18 Petition for exemption from certifi cation. Subpart B—Administrative Action on Petitions 71.20 Publication of regulation. 71.22 Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued. 71.25 Condition for certification. 71.26 Revocation of exemption from certifi cation. 71.27 Listing and exemption from certifi cation on the Commissioner’s initiative. 71.30 Procedure for filing objections to regu lations. 71.37 Exemption of color additives for inves tigational use. AUTHORITY: 21 U.S.C. 321, 342, 348, 351, 355, 360, 360b–360f, 360h–360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262. SOURCE: 42 FR 15639, Mar. 22, 1977, unless otherwise noted. Subpart A—General Provisions § 71.1 Petitions. (a) Any interested person may pro pose the listing of a color additive for use in or on any food, drug, or cosmetic or for coloring the human body. Such proposal shall be made in a petition in the form prescribed in paragraph (c) of this section. The petition shall be sub mitted in triplicate (quadruplicate, if intended uses include uses in meat, meat food product, or poultry product). If any part of the material submitted is in a foreign language, it shall be ac companied by an accurate and com plete English translation. The peti tioner shall state the post-office ad dress in the United States to which published notices or orders issued or objections filed pursuant to section 721 of the act may be sent. (b) Pertinent information may be in corporated in, and will be considered as part of, a petition on the basis of spe cific reference to such information sub mitted to and retained in the files of the Food and Drug Administration. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such informa tion is authorized in a written state ment signed by the person who sub mitted the information. Any reference to published information offered in support of a color additive petition should be accompanied by reprints or photostatic copies of such references. (c) Petitions shall include the fol lowing data and be submitted in the following form: lllllllll (Date) Name of petitioner lllllllllllll Post-office address lllllllllllll VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00404 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 395 Food and Drug Administration, HHS § 71.1 Name of color additive and proposed use ll Office of Food Additive Safety (HFS–200), Center for Food Safety and Applied Nutri tion, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 Dear Sir: Petitioner submits this pursuant to sec tion 721(b)(1) of the Federal Food, Drug, and Cosmetic Act requesting listing by the Com missioner of the color additive lllll as suitable and safe for use in or on lllll subject to the conditions that lllllll. [Petitioner may propose a listing for general use in food, drugs, or cosmetics or, if such general listing is not believed suitable and safe, the petitioner shall describe the condi tions under which he believes the additive can be safely used and for which it will be suitable. These conditions may include toler ance limitations, specifications as to the manner in which the additive may be added or used, and directions and other labeling or packaging safeguards that should be applied. The level of use proposed should not be high er than reasonably required to accomplish the intended color effect.] Attached hereto, in triplicate (quadru plicate, if intended uses include uses in meat, meat food product, or poultry prod uct), and constituting a part of this petition are the following: A. The name and all pertinent information concerning the color additive, including chemical identity and composition of the color additive, its physical, chemical, and bi ological properties, and specifications pre scribing its component(s) and identifying and limiting the reaction byproducts and other impurities. The petition shall contain a description of the chemical and physical tests relied upon to identify the color additive and shall con tain a full description of the methods used in, and the facilities and controls used for, the production of the color additive. These shall establish that it is a substance of re producible composition. Alternative methods and controls and variations in methods and controls, within reasonable limits, that do not affect the characteristics of the sub stance or the reliability of the controls may be specified. The petition shall supply a list of all sub stances used in the synthesis, extraction, or other method of preparation of any straight color, regardless of whether they undergo chemical change in the process. Each sub stance should be identified by its common or usual name and its complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used as a component, the pro prietary name should be followed by a com plete quantitive statement of composition. Reasonable alternatives for any listed sub stance may be specified. If the petitioner does not himself perform all the manufacturing, processing, and pack ing operations for a color additive, the peti tioner shall identify each person who will perform a part of such operations and des ignate the part. The petition shall include stability data, and, if the data indicate that it is needed to insure the identity, strength, quality, or pu rity of the color additive, the expiration pe riod that will be employed as well as any packaging and labeling precautions needed to preserve stability. B. The amount of the color additive pro posed for use and the color effect intended to be achieved, together with all directions, recommendations, and suggestions regarding the proposed use, as well as specimens of the labeling proposed for the color additive. If the color effect results or may reasonably be expected to result from use of the color addi tive in packaging material, the petitioner shall show how this may occur and what res idues may reasonably be anticipated. Typewritten or other draft-labeling copy will be accepted for consideration of the pe tition provided final printed labeling iden tical in content to the draft copy is sub mitted as soon as available, and prior to the marketing of the color additive. The printed labeling shall conform in prominence and conspicuousness with the requirements of the act. If the color additive is one for which a tol erance limitation is required to assure its safety, the level of use proposed should be no higher than the amount reasonably required to accomplish the intended physical or other technical effect, even though the safety data may support a higher tolerance. If the safety data will not support the use of the amount of the color additive reasonably needed to accomplish the desired color effect, the re quested tolerance will not be established. Pe titioners are expected to propose the use of color additives in accordance with sound color chemistry. C.1. A description of practicable methods to determine the pure color and all inter mediates, subsidiary colors, and other com ponents of the color additive. 2. A description of practicable methods to determine the amount of the color additive in any raw, processed, and/or finished food, drug, or cosmetic in which use of the color additive is proposed. (The tests proposed shall be those that can be used for food, drug, or cosmetic control purposes and can be ap plied with consistent results by any properly equipped laboratory and trained personnel.) 3. A description of methods for identifica tion and determination of any substance formed in or on such food, drug, or cosmetic because of the use of the color additive. (If it VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00405 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 396 21 CFR Ch. I (4–1–16 Edition) § 71.1 is the petitioner’s view that any such meth od would not be needed, under the terms of section 721(b)(5)(A)(iv), a statement shall be submitted in lieu of methods as to the basis for such view.) D. Full reports of investigation made with respect to the safety of the color additive. (A petition will be regarded as incomplete unless it includes full reports of adequate tests reasonably applicable to show whether or not the color additive will be safe for its intended use. The reports ordinarily should include detailed data derived from appro priate animal and other biological experi ments in which the methods used and the re sults obtained are clearly set forth. The peti tion shall not omit without explanation any data that would influence the evaluation of the safety of the color additive). E. Complete data which will allow the Commissioner to consider, among other things, the probable consumption of, and/or other relevant exposure from the additive and of any substance formed in or on food, drugs, or cosmetics because of such additive; and the cumulative effect, if any, of such ad ditive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or sub stances in the diet including, but not limited to food additives and pesticide chemicals for which tolerances or exemptions from toler ances have been established. F. Proposed tolerances and other limita tions on the use of the color additive, if tol erances and limitations are required in order to insure its safety. A petitioner may include a proposed regulation. G. If exemption from batch certification is requested, the reasons why it is believed such certification is not necessary (including supporting data to establish the safety of the intended use). H. If submitting a petition to alter an ex isting regulation issued pursuant to section 721(b) of the act, full information on each proposed change that is to be made in the original regulation must be submitted. The petition may omit statements made in the original petition concerning which no change is proposed. A supplemental petition must be submitted for any change beyond the variations provided for in the original petition and the regulation issued on the basis of the original petition. I. The prescribed fee of $llllll for ad mitting the color additive to listing is en closed (unless there is an advance deposit adequate to cover the fee). Yours very truly, (Petitioner) lllllllllllllllll By lllllll (Indicate authority) J. The petitioner is required to submit ei ther a claim for categorical exclusion under § 25.30 or 25.32 of this chapter or an environ mental assessment under § 25.40 of this chap ter. (d) The petitioner will be notified of the date on which his petition is filed; and an incomplete petition, or one that has not been submitted in triplicate, will be retained but not filed. A peti tion shall be retained but shall not be filed if any of the data listed in the above form are lacking or are not set forth so as to be readily understood or if the prescribed fee has not been sub mitted. The petitioner will be notified in what respects his petition is incom plete. (e) The petition must be signed by the petitioner or by his attorney or au thorized agent, who is a resident of the United States. (f) The data specified under the sev eral lettered headings should be sub mitted on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present peti tion may incorporate it by specific ref erence to the earlier petition. (g) If nonclinical laboratory studies are involved, petitions filed with the Commissioner under section 721(b) of the act shall include with respect to each nonclinical study contained in the petition, either a statement that the study was conducted in compliance with the good laboratory practice regu lations set forth in part 58 of this chap ter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. (h) [Reserved] (i) If clinical investigations involving human subjects are involved, petitions filed with the Commissioner under sec tion 721(b) of the act shall include statements regarding each such clin ical investigation contained in the pe tition that it either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with §§ 56.104 or 56.105, and that it was con ducted in compliance with the require ments for informed consent set forth in part 50 of this chapter. (j)(1) If intended uses of the color ad ditive include uses in meat, meat food product, or poultry product subject to VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00406 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 397 Food and Drug Administration, HHS § 71.6 regulation by the U.S. Department of Agriculture (USDA) under the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the peti tion, forward a copy of the petition or relevant portions thereof to the Food Safety and Inspection Service, USDA, for simultaneous review under the PPIA and FMIA. (2) FDA will ask USDA to advise whether the proposed meat and poultry uses comply with the FMIA and PPIA or, if not, whether use of the substance would be permitted in products under USDA jurisdiction under specified con ditions or restrictions. [42 FR 15639, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR 24890, June 12, 1989; 61 FR 14478, Apr. 2, 1996; 62 FR 40598, July 29, 1997; 65 FR 51762, Aug. 25, 2000; 66 FR 56035, Nov. 6, 2001] § 71.2 Notice of filing of petition. (a) Except where the petition in volves a new drug, the Commissioner, within 15 days after receipt, will notify the petitioner of acceptance or non acceptance of a petition, and if not ac cepted the reasons therefor. If accept ed, the date of the notification letter sent to petitioner becomes the date of filing for the purposes of section 721(d)(1) of the act. If the petitioner de sires, he may supplement a deficient petition after being notified regarding deficiencies. If the supplementary ma terial or explanation of the petition is deemed acceptable, petitioner shall be notified. The date of such notification becomes the date of filing. If the peti tioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the peti tioner so notified. The date of such no tification becomes the date of filing. Where the petition involves a new drug, notification to the petitioner will be made in accordance with § 70.10(b)(3) of this chapter. (b) The Commissioner will cause to be published in the FEDERAL REGISTER within 30 days from the date of filing of such petition a notice of the filing, the name of the petitioner, and a brief de scription of the proposal in general terms. A copy of the notice will be mailed to the petitioner when the original document is signed. [42 FR 15639, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999] § 71.4 Samples; additional information. The Commissioner may request sam ples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, and any additional information needed to clarify a submitted method or other as pect of a petition at any time while a petition is under consideration. The Commissioner shall specify in the re quest for a sample of the color addi tive, or articles used as components thereof, or of the food, drug, or cos metic in which the color additive is proposed to be used, or which com prises the color additive, a quantity deemed adequate to permit tests of an alytical methods to determine quan tities of the color additive present in products for which it is intended to be used or adequate for any study or in vestigation reasonably required with respect to the safety of the color addi tive or the physical or technical effect it produces. The date used for com puting the 90-day limit for the purposes of section 721(d)(1) of the act shall be moved forward 1 day for each day, after mailing date of the request, taken by the petitioner to submit the informa tion and/or sample. If the information or sample is requested a reasonable time in advance of the 180 days, but is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice. § 71.6 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice. (a) Extension of time for studying peti tions. If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner ex tend the 90-day period for not more than 180 days after the filing of the pe tition. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00407 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 398 21 CFR Ch. I (4–1–16 Edition) § 71.15 (b) Substantive amendments. After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amounts to a substantive amendment, the petition as amended will be given a new filing date, and the time limita tion will begin to run anew. If nonclin ical laboratory studies are involved, additional information and data sub mitted in support of filed petitions shall include, with respect to each non clinical laboratory study contained in the petition, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. If clin ical investigations involving human subjects are involved, additional infor mation or data submitted in support of filed petitions shall include statements regarding each such clinical investiga tion from which the information or data are derived, that it either was conducted in compliance with the re quirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in ac cordance with § 56.104 or § 56.105, and that it was conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter. (c) Withdrawal of petitions without prejudice. (1) In some cases the Com missioner may notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or com plete. In such cases, the petitioner may withdraw the petition pending its clari fication or the obtaining of additional data. This withdrawal will be without prejudice to a future filing. Upon re filing, the time limitation will begin to run anew from the date of refiling. (2) At any time before the order pro vided for in § 71.20 has been forwarded to the FEDERAL REGISTER for publica tion the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling, the time limita tion will begin to run anew. [42 FR 15636, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985] § 71.15 Confidentiality of data and in formation in color additive peti tions. (a) The following data and informa tion in a color additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filing of the petition is published in the FEDERAL REGISTER or, if the petition is not promptly filed because of deficiencies in it, after the petitioner is informed that it will not be filed because of the deficiencies involved: (1) All safety and functionality data and information submitted with or in corporated by reference in the petition. (2) A protocol for a test or study, un less it is shown to fall within the ex emption established for trade secrets and confidential commercial informa tion in § 20.61 of this chapter. (3) Adverse reaction reports, product experience reports, consumer com plaints, and other similar data and in formation, after deletion of: (i) Names and any information that would identify the person using the product. (ii) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution. (4) A list of all ingredients contained in a color additive, whether or not it is in descending order of predominance. A particular ingredient or group of ingre dients shall be deleted from any such list prior to public disclosure if it is shown to fall within the exemption es tablished in § 20.61 of this chapter, and a notation shall be made that any such ingredient list is incomplete. (5) An assay method or other analyt ical method, unless it serves no regu latory or compliance purpose and is shown to fall within the exemption es tablished in § 20.61 of this chapter. (6) All records showing the Food and Drug Administration’s testing of or ac tion on a particular lot of a certifiable color additive. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00408 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 399 Food and Drug Administration, HHS § 71.20 (b) The following data and informa tion in a color additive petition are not available for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or fi nancial information as defined in § 20.61 of this chapter: (1) Manufacturing methods or proc esses, including quality control proce dures. (2) Production, sales, distribution, and similar data and information, ex cept that any compilation of such data and information aggregated and pre pared in a way that does not reveal data or information which is not avail able for public disclosure under this provision is available for public disclo sure. (3) Quantitative or semiquantitative formulas. (c) All correspondence and written summaries of oral discussions relating to a color additive petition are avail able for public disclosure in accordance with the provisions of part 20 of this chapter when the color additive regula tion is published in the FEDERAL REG ISTER. (d) For purposes of this regulation, safety and functionality data include all studies and tests of a color additive on animals and humans and all studies and tests on a color additive for iden tity, stability, purity, potency, per formance, and usefulness. § 71.18 Petition for exemption from certification. A manufacturer, packer, or dis tributor of a color additive or color ad ditive mixture may petition for an ex emption from certification pursuant to part 10 of this chapter. Any such peti tion shall show why such certification is not necessary for the protection of public health. Subpart B—Administrative Action on Petitions § 71.20 Publication of regulation. The Commissioner will forward for publication in the FEDERAL REGISTER, within 90 days after filing of the peti tion (or within 180 days if the time is extended as provided for in section 721(d)(1) of the act): (a) A regulation listing in part 73 or 74 of this chapter the color additive on the appropriate list or lists as provided under section 721(b)(1). (1) Such a regulation may list the color additive for use generally in or on foods, drugs, or cosmetics or for use in coloring the human body, as the case may be, or may prescribe the condi tions under which the color additive may be safely used (including, but not limited to, specifications as to the par ticular food, drug, or cosmetic or class es of food, drugs, or cosmetics in or on which such color additive may be used, or for the material intended for color ing the human body; the maximum quantity of any straight color or dil uent that may be used or permitted to remain in or on such food, drug, or cos metic or article intended for coloring the human body; the manner in which such color additive may be added to or used in or on such food, drug, or cos metic or for coloring the human body; and any directions or other labeling or packing requirements for such color additives deemed necessary to assure the safety of such use). (2) Such regulations shall list the color additive only for the use or uses for which it has been found suitable and for which it may safely be em ployed. Alternatively, the Commis sioner shall by order deny the petition, and notify the petitioner of such order and the reasons therefor. (3) The regulation shall list any use or uses in meat, meat food product, or poultry product subject to the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products In spection (PPIA) (21 U.S.C. 451 et seq.) for which the color additive has been found suitable and for which it may safely be employed. (b) Whenever the Commissioner finds that batch certification is not nec essary for the protection of the public health he will, by order, exempt the color additive from the certification procedure. In determining whether cer tification of a color additive is nec essary, the Commissioner will consider the composition of the additive, its VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00409 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 400 21 CFR Ch. I (4–1–16 Edition) § 71.22 manufacturing process, possible impu rities, its toxic potential, control and analytical procedures necessary to as sure compliance with the listing speci fications, and the variability of its composition. [42 FR 15639, Mar. 22, 1977, as amended at 65 FR 51762, Aug. 25, 2000] § 71.22 Deception as a basis for refus ing to issue regulations; deceptive use of a color additive for which a regulation has issued. The Commissioner shall refuse to issue a regulation listing a color addi tive, if in his judgment the data before him show that such proposed use would promote deception of the consumer or would result in misbranding or adulter ation within the meaning of the act. Such a finding shall be by order pub lished in the FEDERAL REGISTER sub ject to the filing of objections and a re quest for a hearing by adversely af fected parties. The issuance of a regu lation for a color additive authorizing its use generally in or on a food, drug, or cosmetic shall not be construed as authorization to use the color additive in a manner that may promote decep tion or conceal damage or inferiority. The use of a color additive to promote deception or conceal damage or inferi ority shall be considered as the use of a color additive for which no regula tion has issued pursuant to section 721(b) of the act, even though the regu lation is effective for other uses. § 71.25 Condition for certification. (a) When the Commissioner cannot conclude from the information before him that there is a basis for exempting a color additive from the requirement of batch certification, he will so order by appropriate listing in part 74 of this chapter. The Commissioner’s order shall state in detail the specifications that shall be met by the color additive. (b) Each order shall state a period of time after which use of a color additive subject to batch certification but not from a batch certified by procedure prescribed in this section would result in adulteration of the product in which it is used. § 71.26 Revocation of exemption from certification. If information becomes available to the Commissioner that a color additive that has been granted exemption from certification should not, for the protec tion of the public health, be so exempt ed, such exemption will be canceled by a notice published in the FEDERAL REG ISTER. § 71.27 Listing and exemption from certification on the Commissioner’s initiative. Where a petition for a regulation to list a color additive has not been re ceived and the Commissioner has avail able facts which demonstrate that a color additive should be listed and/or that certification procedure is not nec essary in order to protect the public health, he may list such color additive by appropriate regulation and listing in part 73 or 74 of this chapter. § 71.30 Procedure for filing objections to regulations. (a) Objections and hearings relating to color additive regulations under sec tion 721 (b) and (c) of the act shall be governed by parts 10, 12, 13, 14, 15, 16, and 19 of this chapter. (b) The fees specified in § 70.19 of this chapter shall be applicable. § 71.37 Exemption of color additives for investigational use. (a) A shipment or other delivery of a color additive or of a food, drug, or cos metic containing such a color additive for investigational use by experts qualified to determine safety shall be exempt from the requirements of sec tion 402(c), 501(a), or 601(e) of the act, provided that the color additive or the food, drug, or cosmetic containing the color additive bears a label which states prominently, ‘‘Caution—Con tains new color additive—For inves tigational use only.’’ No animals used in such investigations, or their prod ucts, such as milk or eggs, shall be used for food purposes, unless the spon sor or the investigator has submitted to the Commissioner data dem onstrating that such use will be con sistent with the public health, and the Commissioner, proceeding as he would in a matter involving section 409(i) of VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00410 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 401 Food and Drug Administration, HHS Pt. 73 the act, has notified the sponsor or in vestigator that the proposed disposi tion for food is authorized. Any person who contests a refusal to grant such authorization shall have an oppor tunity for a regulatory hearing before the Food and Drug Administration pur suant to part 16 of this chapter. (b) The person who introduced such shipment or who delivers the color ad ditive or a food, drug, or cosmetic con taining such an additive into interstate commerce shall maintain adequate records showing the name and post-of fice address of the expert to whom the color additive is shipped, date, quan tity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment and delivery. Upon the request of a properly author ized employee of the Department, at reasonable times, he shall make such records available for inspection and copying. PART 73—LISTING OF COLOR AD DITIVES EXEMPT FROM CERTIFI CATION Subpart A—Foods Sec. 73.1 Diluents in color additive mixtures for food use exempt from certification. 73.30 Annatto extract. 73.35 Astaxanthin. 73.37 Astaxanthin dimethyldisuccinate. 73.40 Dehydrated beets (beet powder). 73.50 Ultramarine blue. 73.75 Canthaxanthin. 73.85 Caramel. 73.90 b-Apo-8′-carotenal. 73.95 b-Carotene. 73.100 Cochineal extract; carmine. 73.125 Sodium copper chlorophyllin. 73.140 Toasted partially defatted cooked cottonseed flour. 73.160 Ferrous gluconate. 73.165 Ferrous lactate. 73.169 Grape color extract. 73.170 Grape skin extract (enocianina). 73.185 Haematococcus algae meal. 73.200 Synthetic iron oxide. 73.250 Fruit juice. 73.260 Vegetable juice. 73.275 Dried algae meal. 73.295 Tagetes (Aztec marigold) meal and extract. 73.300 Carrot oil. 73.315 Corn endosperm oil. 73.340 Paprika. 73.345 Paprika oleoresin. 73.350 Mica-based pearlescent pigments. 73.352 Paracoccus pigment. 73.355 Phaffia yeast. 73.450 Riboflavin. 73.500 Saffron. 73.530 Spirulina extract. 73.575 Titanium dioxide. 73.585 Tomato lycopene extract; tomato ly copene concentrate. 73.600 Turmeric. 73.615 Turmeric oleoresin. Subpart B—Drugs 73.1001 Diluents in color additive mixtures for drug use exempt from certification. 73.1010 Alumina (dried aluminum hydrox ide). 73.1015 Chromium-cobalt-aluminum oxide. 73.1025 Ferric ammonium citrate. 73.1030 Annatto extract. 73.1070 Calcium carbonate. 73.1075 Canthaxanthin. 73.1085 Caramel. 73.1095 b-Carotene. 73.1100 Cochineal extract; carmine. 73.1125 Potassium sodium copper chlorophyllin (chlorophyllin-copper com plex). 73.1150 Dihydroxyacetone. 73.1162 Bismuth oxychloride. 73.1200 Synthetic iron oxide. 73.1298 Ferric ammonium ferrocyanide. 73.1299 Ferric ferrocyanide. 73.1326 Chromium hydroxide green. 73.1327 Chromium oxide greens. 73.1329 Guanine. 73.1350 Mica-based pearlescent pigments. 73.1375 Pyrogallol. 73.1400 Pyrophyllite. 73.1410 Logwood extract. 73.1496 Mica. 73.1530 Spirulina extract. 73.1550 Talc. 73.1575 Titanium dioxide. 73.1645 Aluminum powder. 73.1646 Bronze powder. 73.1647 Copper powder. 73.1991 Zinc oxide. Subpart C—Cosmetics 73.2030 Annatto. 73.2085 Caramel. 73.2087 Carmine. 73.2095 b-Carotene. 73.2110 Bismuth citrate. 73.2120 Disodium EDTA-copper. 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper com plex). 73.2150 Dihydroxyacetone. 73.2162 Bismuth oxychloride. 73.2180 Guaiazulene. 73.2190 Henna. 73.2250 Iron oxides. 73.2298 Ferric ammonium ferrocyanide. 73.2299 Ferric ferrocyanide. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00411 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B