Food additive petitions (21 CFR 171.1-171.130)

24 21 CFR Ch. I (4–1–16 Edition) § 170.106 longer safe, FDA may determine that the authorizing FCN is no longer effec tive. (b) If FDA determines that an FCN is no longer effective, FDA will inform the manufacturer or supplier in writing of the basis for that determination. FDA will give the manufacturer or sup plier an opportunity to show why the FCN should continue to be effective and will specify the time that the man ufacturer or supplier will have to re spond. (c) If the manufacturer or supplier fails to respond adequately to the safe ty concerns regarding the notified use, FDA will publish a notice of its deter mination that the FCN is no longer ef fective. FDA will publish this notice in the FEDERAL REGISTER, stating that a detailed summary of the basis for FDA’s determination that the FCN is no longer effective has been placed on public display and that copies are available upon request. The date that the notice publishes in the FEDERAL REGISTER is the date on which the noti fication is no longer effective. (d) FDA’s determination that an FCN is no longer effective is final agency action subject to judicial review. § 170.106 Notification for a food con tact substance formulation (NFCSF). (a) In order for the Food and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the formulation must be authorized for its intended use in that NFCSF. (b) FDA may publish a notice in the FEDERAL REGISTER stating that the agency has insufficient resources to re view NFCSFs. From the date that this notice publishes in the FEDERAL REG ISTER, FDA will no longer accept NFCSFs. (c) An NFCSF must contain the fol lowing: (1) A completed and signed FDA Form No. 3479; and (2) Any additional documentation re quired to establish that each compo nent of the formulation already may be marketed legally for its intended use. PART 171—FOOD ADDITIVE PETITIONS Subpart A—General Provisions Sec. 171.1 Petitions. 171.6 Amendment of petition. 171.7 Withdrawal of petition without preju dice. 171.8 Threshold of regulation for substances used in food-contact articles. Subpart B—Administrative Actions on Applications 171.100 Regulation based on petition. 171.102 Effective date of regulation. 171.110 Procedure for objections and hear ings. 171.130 Procedure for amending and repeal ing tolerances or exemptions from toler ances. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14489, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 171.1 Petitions. (a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadru plicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state petitioner’s post of fice address to which published notices or orders issued or objections filed pur suant to section 409 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 it. Any reference to published information offered in support of a food VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00034 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 25 Food and Drug Administration, HHS § 171.1 additive petition should be accom panied by reprints or photostatic cop ies of such references. (c) Petitions shall include the fol lowing data and be submitted in the following form: (Date) Name of petitioner lllllllllllll Post-office address lllllllllllll Date lllllllllllllllllllll Name of food additive and proposed use ll llllllllllllllllllllllll 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 SIRS: The undersigned, lllll submits this petition pursuant to section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with respect to lllll (Name of the food additive and proposed use) Attached hereto, in triplicate (quadru plicate, if intended uses include use in meat, meat food product, or poultry product), and constituting a part of this petition are the following: A. The name and all pertinent information concerning the food additive, including chemical identity and composition of the food additive, its physical, chemical, and bi ological properties, and specifications pre scribing the minimum content of the desired component(s) and identifying and limiting the reaction byproducts and other impuri ties. Where such information is not avail able, a statement as to the reasons why it is not should be submitted. When the chemical identity and composi tion of the food additive is not known, the petition shall contain information in suffi cient detail to permit evaluation regarding the method of manufacture and the analyt ical controls used during the various stages of manufacturing, processing, or packing of the food additive which are relied upon to es tablish that it is a substance of reproducible composition. Alternative methods and con trols and variations in methods and controls within reasonable limits that do not affect the characteristics of the substance or the reliability of the controls may be specified. If the food additive is a mixture of chemi cals, the petition shall supply a list of all substances used in the synthesis, extraction, or other method of preparation, regardless of whether they undergo chemical change in the process. Each substance should be identi fied by its common English name and com plete chemical name, using structural for mulas when necessary for specific identifica tion. If any proprietary preparation is used as a component, the proprietary name should be followed by a complete quantitative statement of composition. Reasonable alter natives for any listed substance may be spec ified. If the petitioner does not himself perform all the manufacturing, processing, and pack ing operations for a food additive, the peti tion shall identify each person who will per form a part of such operations and designate 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 additive, the expiration date that will be employed. B. The amount of the food additive pro posed for use and the purposes for which it is proposed, together with all directions, rec ommendations, and suggestions regarding the proposed use, as well as specimens of the labeling proposed for the food additive and any labeling that will be required by applica ble provisions of the Federal Food, Drug, and Cosmetic Act on the finished food by reason of the use of the food additive. If the additive results or may reasonably be expected to re sult from the use of packaging material, the petitioner shall show how this may occur and what residues may reasonably be antici pated. (Typewritten or other draft-labeling copy will be accepted for consideration of the pe tition, provided a statement is made that final printed labeling identical in content to the draft copy will be submitted as soon as available and prior to the marketing of the food additive.) (If the food 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.) C. Data establishing that the food additive will have the intended physical or other technical effect or that it may reasonably be expected to become a component, or to affect the characteristics, directly or indirectly, of food and the amount necessary to accom plish this. These data should include infor mation in sufficient detail to permit evalua tion with control data. D. A description of practicable methods to determine the amount of the food additive in the raw, processed, and/or finished food and of any substance formed in or on such food because of its use. The test proposed shall be one that can be used for food-control pur poses and that can be applied with consistent results by any properly equipped and trained laboratory personnel. E. Full reports of investigations made with respect to the safety of the food additive. (A petition may be regarded as incomplete unless it includes full reports of adequate tests reasonably applicable to show whether VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00035 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 26 21 CFR Ch. I (4–1–16 Edition) § 171.1 or not the food 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 reports of investigations that would bias an evaluation of the safety of the food additive.) F. Proposed tolerances for the food addi tive, if tolerances are required in order to in sure its safety. A petitioner may include a proposed regulation. G. If submitting petition to modify an ex isting regulation issued pursuant to section 409(c)(1)(A) 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. H. 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. Yours very truly, Petitioner llllllllllllllllll By llllllllllllllllllllll (Indicate authority) (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 usually be retained but not filed as a petition under section 409 of the Act. The petitioner will be notified in what respects his petition is incomplete. (e) The petition must be signed by the petitioner or by his attorney or agent, or (if a corporation) by an au thorized official. (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. If part of the data have been submitted by the manufac turer of the food additive as a master file, the petitioner may refer to the master file if and to the extent he ob tains the manufacturer’s written per mission to do so. The manufacturer may authorize specific reference to the data without disclosure to the peti tioner. Nothing herein shall prevent reference to published data. (g) A petition shall be retained but shall not be filed if any of the data pre scribed by section 409(b) of the Act are lacking or are not set forth so as to be readily understood. (h)(1) The following data and infor mation in a food 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: (i) All safety and functionality data and information submitted with or in corporated by reference in the petition. (ii) 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. (iii) Adverse reaction reports, prod uct experience reports, consumer com plaints, and other similar data and in formation, after deletion of: (a) Names and any information that would identify the person using the product. (b) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution. (iv) A list of all ingredients contained in a food 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. (v) 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. (2) The following data and informa tion in a food 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00036 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 27 Food and Drug Administration, HHS § 171.1 and they no longer represent a trade secret or confidential commercial or fi nancial information as defined in § 20.61 of this chapter: (i) Manufacturing methods or proc esses, including quality control proce dures. (ii) 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. (iii) Quantitative or semiquantita tive formulas. (3) All correspondence and written summaries of oral discussions relating to a food additive petition are avail able for public disclosure in accordance with the provisions of part 20 of this chapter when the food additive regula tion is published in the FEDERAL REG ISTER. (4) For purposes of this regulation, safety and functionality data include all studies and tests of a food additive on animals and humans and all studies and tests on a food additive for iden tity, stability, purity, potency, per formance, and usefulness. (i)(1)(i) Within 15 days after receipt, the Food and Drug Administration will notify the petitioner of the acceptance or nonacceptance of a petition, and if not accepted, the reasons therefor. If accepted, the petitioner will be sent a letter stating this and the date of the letter shall become the date of filing for the purposes of section 409(b)(5) of the act. In cases in which the Food and Drug Administration agrees that a pre market notification for a food contact substance (Food Contact Notification (FCN)) submitted under section 409(h) of the act may be converted to a peti tion, the withdrawal date for the FCN will be deemed the date of receipt for the petition. (ii) If the petitioner desires, he may supplement a deficient petition after being notified regarding deficiencies. If the supplementary material or expla nation of the petition is deemed ac ceptable, the petitioner shall be noti fied. The date of such notification be comes 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. (iii) Notwithstanding paragraph (i)(1)(ii) of this section, the petition shall not be filed if the Food and Drug Administration determines that the use identified in the petition should be the subject of an FCN under section 409(h) of the act rather than a petition. (2) The Commissioner will publish 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 description of the proposal in general terms. In the case of a food additive which becomes a component of food by migration from packaging material, the notice shall include the name of the migratory sub stance, and where it is different from that of one of the original components, the name of the parent component, the maximum quantity of the migratory substance that is proposed for use in food, and the physical or other tech nical effect which the migratory sub stance or its parent component is in tended to have in the packaging mate rial. A copy of the notice will be mailed to the petitioner when the original is forwarded to the FEDERAL REGISTER for publication. (j) The Commissioner may request a full description of the methods used in, and the facilities and controls used for, the production of the food additive, or a sample of the food additive, articles used as components thereof, or of the food in which the additive is proposed to be used, at any time while a petition is under consideration. The Commis sioner shall specify in the request for a sample of the food additive, or articles used as components thereof, or of the food in or on which the additive is pro posed to be used, a quantity deemed adequate to permit tests of analytical methods to determine quantities of the food additive present in foods for which it is intended to be used or adequate for any study or investigation reason ably required with respect to the safety of the food additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 409(c)(2) of the VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00037 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 28 21 CFR Ch. I (4–1–16 Edition) § 171.6 Act shall be moved forward 1 day for each day after the mailing date of the request taken by the petitioner to sub mit the 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 prej udice. (k) If nonclinical laboratory studies are involved, petitions filed with the Commissioner under section 409(b) of the act shall include, with respect to each nonclinical study contained in the petition, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. (l) [Reserved] (m) If clinical investigations involv ing human subjects are involved, peti tions filed with the Commissioner under section 409(b) of the Act shall in clude statements regarding each such clinical investigation relied upon in the petition that it either was con ducted in compliance with the require ments for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accord ance 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. (n)(1) If intended uses of the food ad ditive include uses in meat, meat food product, or poultry product subject to 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 14489, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 62 FR 40599, July 29, 1997; 65 FR 51763, Aug. 25, 2000; 67 FR 35731, May 21, 2002; 72 FR 10357, Mar. 8, 2007] § 171.6 Amendment of petition. After a petition has been filed, the petitioner may submit additional in formation or data in support thereof. In such cases, if the Commissioner de termines that the additional informa tion or data amount to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew. If nonclinical laboratory studies are in volved, additional information and data submitted in support of filed peti tions shall include, with respect to each nonclinical study, either a state ment 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 compli ance with such regulations, a brief statement of the reason for the non compliance. [50 FR 7492, Feb. 22, 1985, as amended at 50 FR 16668, Apr. 26, 1985] § 171.7 Withdrawal of petition without prejudice. (a) In some cases the Commissioner will notify the petitioner that the peti tion, while technically complete, is in adequate to justify the establishment of a regulation or the regulation re quested by petitioner. This may be due to the fact that the data are not suffi ciently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This with drawal will be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling. (b) At any time before the order pro vided for in § 171.100(a) has been for warded to the FEDERAL REGISTER for publication, the petitioner may with draw the petition without prejudice to a future filing. Upon refiling the time limitation will begin to run anew. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00038 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 29 Food and Drug Administration, HHS § 171.130 (c) Any petitioner who has a food ad ditive petition pending before the agen cy and who subsequently submits a premarket notification for a food con tact substance (FCN) for a use or uses described in such petition shall be deemed to have withdrawn the petition for such use or uses without prejudice to a future filing on the date the FCN is received by the Food and Drug Ad ministration. [42 FR 14489, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002] § 171.8 Threshold of regulation for substances used in food-contact ar ticles. Substances used in food-contact arti cles (e.g., food-packaging or food-proc essing equipment) that migrate or that may be expected to migrate into food at negligible levels may be reviewed under § 170.39 of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in § 170.39 of this chapter from regulation as food addi tives and, therefore, a food additive pe tition will not be required for the ex empted use. [60 FR 36596, July 17, 1995] Subpart B—Administrative Actions on Applications § 171.100 Regulation based on petition. (a) The Commissioner will forward for publication in the FEDERAL REG ISTER, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 409(c)(2) of the Act), a regulation pre scribing the conditions under which the food additive may be safely used (including, but not limited to, speci fications as to the particular food or classes of food in or on which such ad ditive may be used, the maximum quantity that may be used or per mitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such addi tive deemed necessary by him to assure the safety of such use), and prior to the forwarding of the order to the FEDERAL REGISTER for publication shall notify the petitioner of such order and the reasons for such action; or by order deny the petition, and shall notify the petitioner of such order and of the rea sons for such action. (b) The regulation shall describe the conditions under which the substance may be safely used in any meat prod uct, meat food product, or poultry product subject to the Federal Meat In spection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspec tion Act (PPIA) (21 U.S.C. 451 et seq.). (c) 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. [42 FR 14489, Mar. 15, 1977, as amended at 65 FR 51763, Aug. 25, 2000] § 171.102 Effective date of regulation. A regulation published in accordance with § 171.100(a) shall become effective upon publication in the FEDERAL REG ISTER. § 171.110 Procedure for objections and hearings. Objections and hearings relating to food additive regulations under section 409 (c), (d), or (h) of the Act shall be governed by part 12 of this chapter. [42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977] § 171.130 Procedure for amending and repealing tolerances or exemptions from tolerances. (a) The Commissioner, on his own initiative or on the petition of any in terested person, pursuant to part 10 of this chapter, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive or granting or repealing an exception for such additive. (b) Any such petition shall include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chem ical, or that experience with the exist ing regulation or exemption may jus tify its amendment or repeal. New data VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00039 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 30 21 CFR Ch. I (4–1–16 Edition) Pt. 172 shall be furnished in the form specified in §§ 171.1 and 171.100 for submitting pe titions. [42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977] PART 172—FOOD ADDITIVES PER MITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMP TION Subpart A—General Provisions Sec. 172.5 General provisions for direct food ad ditives. Subpart B—Food Preservatives 172.105 Anoxomer. 172.110 BHA. 172.115 BHT. 172.120 Calcium disodium EDTA. 172.130 Dehydroacetic acid. 172.133 Dimethyl dicarbonate. 172.135 Disodium EDTA. 172.140 Ethoxyquin. 172.145 Heptylparaben. 172.150 4-Hydroxymethyl-2,6-di-tert-butyl phenol. 172.155 Natamycin (pimaricin). 172.160 Potassium nitrate. 172.165 Quaternary ammonium chloride combination. 172.167 Silver nitrate and hydrogen peroxide solution. 172.170 Sodium nitrate. 172.175 Sodium nitrite. 172.177 Sodium nitrite used in processing smoked chub. 172.180 Stannous chloride. 172.185 TBHQ. 172.190 THBP. Subpart C—Coatings, Films and Related Substances 172.210 Coatings on fresh citrus fruit. 172.215 Coumarone-indene resin. 172.225 Methyl and ethyl esters of fatty acids produced from edible fats and oils. 172.230 Microcapsules for flavoring sub stances. 172.235 Morpholine. 172.250 Petroleum naphtha. 172.255 Polyacrylamide. 172.260 Oxidized polyethylene. 172.270 Sulfated butyl oleate. 172.275 Synthetic paraffin and succinic de rivatives. 172.280 Terpene resin. Subpart D—Special Dietary and Nutritional Additives 172.310 Aluminum nicotinate. 172.315 Nicotinamide-ascorbic acid complex. 172.320 Amino acids. 172.325 Bakers yeast protein. 172.330 Calcium pantothenate, calcium chlo ride double salt. 172.335 D-Pantothenamide. 172.340 Fish protein isolate. 172.345 Folic acid (folacin). 172.350 Fumaric acid and salts of fumaric acid. 172.365 Kelp. 172.370 Iron-choline citrate complex. 172.372 N-Acetyl-L-methionine. 172.375 Potassium iodide. 172.379 Vitamin D2. 172.380 Vitamin D3. 172.381 Vitamin D2 bakers yeast. 172.385 Whole fish protein concentrate. 172.395 Xylitol. 172.399 Zinc methionine sulfate. Subpart E—Anticaking Agents 172.410 Calcium silicate. 172.430 Iron ammonium citrate. 172.480 Silicon dioxide. 172.490 Yellow prussiate of soda. Subpart F—Flavoring Agents and Related Substances 172.510 Natural flavoring substances and natural substances used in conjunction with flavors. 172.515 Synthetic flavoring substances and adjuvants. 172.520 Cocoa with dioctyl sodium sulfo succinate for manufacturing. 172.530 Disodium guanylate. 172.535 Disodium inosinate. 172.540 DL-Alanine. 172.560 Modified hop extract. 172.575 Quinine. 172.580 Safrole-free extract of sassafras. 172.585 Sugar beet extract flavor base. 172.590 Yeast-malt sprout extract. Subpart G—Gums, Chewing Gum Bases and Related Substances 172.610 Arabinogalactan. 172.615 Chewing gum base. 172.620 Carrageenan. 172.623 Carrageenan with polysorbate 80. 172.626 Salts of carrageenan. 172.655 Furcelleran. 172.660 Salts of furcelleran. 172.665 Gellan gum. 172.695 Xanthan gum. Subpart H—Other Specific Usage Additives 172.710 Adjuvants for pesticide use dilu tions. 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