Substances prohibited from use in human food (21 CFR 189.1-189.301)

596 21 CFR Ch. I (4–1–16 Edition) Pt. 189 PART 189—SUBSTANCES PROHIB ITED FROM USE IN HUMAN FOOD Subpart A—General Provisions Sec. 189.1 Substances prohibited from use in human food. Subpart B—Prohibited cattle materials 189.5 Prohibited cattle materials. Subpart C—Substances Generally Prohib ited From Direct Addition or Use as Human Food 189.110 Calamus and its derivatives. 189.113 Cinnamyl anthranilate. 189.120 Cobaltous salts and its derivatives. 189.130 Coumarin. 189.135 Cyclamate and its derivatives. 189.140 Diethylpyrocarbonate (DEPC). 189.145 Dulcin. 189.155 Monochloroacetic acid. 189.165 Nordihydroguaiaretic acid (NDGA). 189.175 P–4000. 189.180 Safrole. 189.190 Thiourea. 189.191 Chlorofluorocarbon propellants. Subpart D—Substances Prohibited From In direct Addition to Human Food Through Food-Contact Surfaces 189.220 Flectol H. 189.240 Lead solders. 189.250 Mercaptoimidazoline and 2 mercaptoimidazoline. 189.280 4,4′-Methylenebis (2-chloroanaline). 189.300 Hydrogenated 4,4′-isopropylidene diphenolphosphite ester resins. 189.301 Tin-coated lead foil capsules for wine bottles. AUTHORITY: 21 U.S.C. 321, 342, 348, 371, 381. SOURCE: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 189 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, 70 FR 40880, July 15, 2005, and 70 FR 67651, Nov. 8, 2005. Subpart A—General Provisions § 189.1 Substances prohibited from use in human food. (a) The food ingredients listed in this section have been prohibited from use in human food by the Food and Drug Administration because of a deter mination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in human food. Use of any of these substances in violation of this section causes the food involved to be adulterated in violation of the act. (b) This section includes only a par tial list of substances prohibited from use in human food, for easy reference purposes, and is not a complete list of substances that may not lawfully be used in human food. No substance may be used in human food unless it meets all applicable requirements of the act. (c) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to establish, amend, or re peal a regulation under this section on the basis of new scientific evaluation or information. Any such petition shall include an adequate scientific basis to support the petition, pursuant to part 10 of this chapter, and will be published for comment if it contains reasonable grounds. [42 FR 14659, Mar. 15, 1977, as amended at 54 FR 24899, June 12, 1989] Subpart B—Prohibited Cattle Materials § 189.5 Prohibited cattle materials. (a) Definitions. The definitions and in terpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part. The following definitions also apply: (1) Prohibited cattle materials means specified risk materials, small intes tine of all cattle except as provided in paragraph (b)(2) of this section, mate rial from nonambulatory disabled cat tle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). Prohibited cattle mate rials do not include the following: (i) Tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, hides and hide-de rived products, and milk and milk products, and (ii) Cattle materials inspected and passed from a country designated under paragraph (e) of this section. (2) Inspected and passed means that the product has been inspected and VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00606 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 597 Food and Drug Administration, HHS § 189.5 passed for human consumption by the appropriate regulatory authority, and at the time it was inspected and passed, it was found to be not adulter ated. (3) Mechanically Separated (MS)(Beef) means a meat food product that is fine ly comminuted, resulting from the me chanical separation and removal of most of the bone from attached skel etal muscle of cattle carcasses and parts of carcasses that meets the speci fications contained in 9 CFR 319.5, the regulation that prescribes the standard of identity for MS (Species). (4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or meta bolic conditions. (5) Specified risk material means the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (exclud ing the vertebrae of the tail, the trans verse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cat tle 30 months and older and the tonsils and distal ileum of the small intestine of all cattle. (6) Tallow means the rendered fat of cattle obtained by pressing or by ap plying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other car cass parts and tissues. Tallow must be produced from tissues that are not pro hibited cattle materials or must con tain not more than 0.15 percent insol uble impurities as determined by the method entitled ‘‘Insoluble Impurities’’ (AOCS Official Method Ca 3a-46), Amer ican Oil Chemists’ Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equiva lent in accuracy, precision, and sensi tivity to AOCS Official Method Ca 3a 46. You may obtain copies of the meth od from AOCS (http://www.aocs.org) 2211 W. Bradley Ave. Champaign, IL 61821. Copies may be examined at the Food and Drug Administration’s Main Li brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (7) Tallow derivative means any chem ical obtained through initial hydrol ysis, saponification, or trans esterification of tallow; chemical con version of material obtained by hydrol ysis, saponification, or trans esterification may be applied to obtain the desired product. (b) Requirements. (1) No human food shall be manufactured from, processed with, or otherwise contain, prohibited cattle materials. (2) The small intestine is not consid ered prohibited cattle material if the distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine, as measured from the caeco-colic junc tion and progressing proximally to wards the jejunum, or by a procedure that the establishment can dem onstrate is equally effective in ensur ing complete removal of the distal ileum. (c) Records. (1) Manufacturers and processors of a human food that is manufactured from, processed with, or otherwise contains, material from cat tle must establish and maintain records sufficient to demonstrate that the food is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. (2) Records must be retained for 2 years after the date they were created. (3) Records must be retained at the manufacturing or processing establish ment or at a reasonably accessible lo cation. (4) The maintenance of electronic records is acceptable. Electronic records are considered to be reasonably accessible if they are accessible from an onsite location. (5) Records required by this section and existing records relevant to com pliance with this section must be avail able to FDA for inspection and copy ing. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00607 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 598 21 CFR Ch. I (4–1–16 Edition) § 189.5, Nt. (6) When filing entry with U.S. Cus toms and Border Protection, the im porter of record of a human food manu factured from, processed with, or oth erwise containing, cattle material must affirm that the food was manu factured from, processed with, or oth erwise contains, cattle material and must affirm that the food was manu factured in accordance with this sec tion. If a human food is manufactured from, processed with, or otherwise con tains, cattle material, then the im porter of record must, if requested, pro vide within 5 days records sufficient to demonstrate that the food is not manu factured from, processed with, or does not otherwise contain, prohibited cat tle material. (7) Records established or maintained to satisfy the requirements of this sub part that meet the definition of elec tronic records in § 11.3(b)(6) of this chapter are exempt from the require ments of part 11 of this chapter. Records that satisfy the requirements of this subpart but that are also re quired under other applicable statutory provisions or regulations remain sub ject to part 11 of this chapter. (d) Adulteration. (1) Failure of a man ufacturer or processor to operate in compliance with the requirements of paragraphs (b) or (c) of this section renders human food adulterated under section 402(a)(4) of the act. (2) Human food manufactured from, processed with, or otherwise con taining, prohibited cattle materials is unfit for human food and deemed adul terated under section 402(a)(3) of the act. (3) Food additive status. Prohibited cattle materials for use in human food are food additives subject to section 409 of the act, except when used as dietary ingredients in dietary supplements. The use or intended use of any prohib ited cattle material in human food causes the material and the food to be adulterated under section 402(a)(2)(C) of the act if the prohibited cattle mate rial is a food additive, unless it is the subject of a food additive regulation or of an investigational exemption for a food additive under § 170.17 of this chap ter. (e) Process for designating countries. A country seeking designation must send a written request to the Director, Of fice of the Center Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, at the address designated in 21 CFR 5.1100. The request shall include information about a country’s bovine spongiform encephalopathy (BSE) case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether specified risk ma terials, the small intestine of cattle ex cept as provided in paragraph (b)(2) of this section, material from non ambulatory disabled cattle, or MS (Beef) from cattle from the country should be considered prohibited cattle materials. FDA shall respond in writ ing to any such request and may im pose conditions in granting any such request. A country designation granted by FDA under this paragraph will be subject to future review by FDA, and may be revoked if FDA determines that it is no longer appropriate. [70 FR 53068, Sept. 7, 2005, as amended at 71 FR 59668, Oct. 11, 2006; 73 FR 20793, Apr. 17, 2008; 81 FR 5596, Feb. 3, 2016] EFFECTIVE DATE NOTE: At 81 FR 14731, Mar. 18, 2016, § 198.5(a) was revised, effective Apr. 18, 2016. For the convenience of the user, the revised text is set forth as follows: § 189.5 Prohibited cattle materials. (a) Definitions. The definitions and inter pretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) apply to such terms when used in this part. The following definitions also apply: (1) Prohibited cattle materials mean specified risk materials, small intestine of all cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory dis abled cattle, material from cattle not in spected and passed, or mechanically sepa rated (MS)(Beef). Prohibited cattle materials do not include the following: (i) Tallow that contains no more than 0.15 percent insoluble impurities, tallow deriva tives, gelatin, hides and hide-derived prod ucts, and milk and milk products, and (ii) Cattle materials inspected and passed from a country designated under paragraph (e) of this section. (2) Inspected and passed means that the product has been inspected and passed for human consumption by the appropriate regu latory authority, and at the time it was in spected and passed, it was found to be not adulterated. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00608 Fmt 8010 Sfmt 8003 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 599 Food and Drug Administration, HHS § 189.113 (3) Mechanically separated (MS) (Beef) means a meat food product that is finely comminuted, resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of cattle car casses and parts of carcasses that meets the specifications contained in 9 CFR 319.5, the U.S. Department of Agriculture regulation that prescribes the standard of identity for MS (Species). (4) Nonambulatory disabled cattle means cat tle that cannot rise from a recumbent posi tion or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paral ysis, fractured vertebral column, or meta bolic conditions. (5) Specified risk material means the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the tho racic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cat tle 30 months of age and older and the tonsils and distal ileum of the small intestine of all cattle. (6) Tallow means the rendered fat of cattle obtained by pressing or by applying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other carcass parts and tissues. Tallow must be produced from tissues that are not prohibited cattle materials or must contain no more than 0.15 percent insoluble impuri ties as determined by the method entitled ‘‘Insoluble Impurities’’ (AOCS Official Meth od Ca 3a-46), American Oil Chemists’ Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equiva lent in accuracy, precision, and sensitivity to AOCS Official Method Ca 3a–46. You may obtain copies of the method from AOCS (http://www.aocs.org) 2211 W. Bradley Ave. Champaign, IL 61821. Copies may be exam ined at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For infor mation on the availability of this material at NARA, call 202–741–6030, or go to http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (7) Tallow derivative means any chemical obtained through initial hydrolysis, saponi fication, or trans-esterification of tallow; chemical conversion of material obtained by hydrolysis, saponification, or trans esterification may be applied to obtain the desired product. (8) Gelatin means a product that has been obtained by the partial hydrolysis of col lagen derived from hides, connective tissue, and/or bone bones of cattle and swine. Gela tin may be either Type A (derived from an acid-treated precursor) or Type B (derived from an alkali-treated precursor) that has gone through processing steps that include filtration and sterilization or an equivalent process in terms of infectivity reduction. * * * * * Subpart C—Substances Generally Prohibited From Direct Addi tion or Use as Human Food SOURCE: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. Redesignated at 69 FR 42273, July 14, 2004. § 189.110 Calamus and its derivatives. (a) Calamus is the dried rhizome of Acorus calamus L. It has been used as a flavoring compound, especially as the oil or extract. (b) Food containing any added calamus, oil of calamus, or extract of calamus is deemed to be adulterated in violation of the act based upon an order published in the FEDERAL REG ISTER of May 9, 1968 (33 FR 6967). (c) The analytical method used for detecting oil of calamus (b-asarone) is in the ‘‘Journal of the Association of Official Analytical Chemists,’’ Volume 56, (Number 5), pages 1281 to 1283, Sep tember 1973, which is incorporated by reference. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, also from the Office of Food Additive Safety (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1200, or available for in spection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. [42 FR 14659, Mar. 15, 1977, as amended at 47 FR 11855, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 78 FR 14667, Mar. 7, 2013] § 189.113 Cinnamyl anthranilate. (a) The food additive cinnamyl an thranilate (C16H15NO2, CAS Reg. No. 87– 29–6) is the ester of cinnamyl alcohol VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00609 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 600 21 CFR Ch. I (4–1–16 Edition) § 189.120 and anthranilic acid. Cinnamyl an thranilate is a synthetic chemical that has not been identified in natural prod ucts at levels detectable by available methodology. It has been used as a fla voring agent in food. (b) Food containing any added cinnamyl anthranilate is deemed to be adulterated in violation of the act based upon an order published in the FEDERAL REGISTER of October 23, 1985. [50 FR 42932, Oct. 23, 1985] § 189.120 Cobaltous salts and its de rivatives. (a) Cobaltous salts are the chemicals, CoC4H6O4, CoCl2, and CoSO4.They have been used in fermented malt beverages as a foam stabilizer and to prevent ‘‘gushing.’’ (b) Food containing any added cobal tous salts is deemed to be adulterated in violation of the act based upon an order published in the FEDERAL REG ISTER of August 12, 1966 (31 FR 8788). § 189.130 Coumarin. (a) Coumarin is the chemical 1,2 benzopyrone, C9H6O2. It is found in tonka beans and extract of tonka beans, among other natural sources, and is also synthesized. It has been used as a flavoring compound. (b) Food containing any added cou marin as such or as a constituent of tonka beans or tonka extract is deemed to be adulterated under the act, based upon an order published in the FED ERAL REGISTER of March 5, 1954 (19 FR 1239). (c) The analytical methods used for detecting coumarin in food are in sec tions 19.016–19.024 of the ‘‘Official Meth ods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by ref erence. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] § 189.135 Cyclamate and its deriva tives. (a) Calcium, sodium, magnesium and potassium salts of cyclohexane sul famic acid, (C6H12NO3S)2Ca, (C6H12NO3S)Na, (C6H12NO3S)2Mg, and (C6H12NO3S)K. Cyclamates are syn thetic chemicals having a sweet taste 30 to 40 times that of sucrose, are not found in natural products at levels de tectable by the official methodology, and have been used as artificial sweet eners. (b) Food containing any added or de tectable level of cyclamate is deemed to be adulterated in violation of the act based upon an order published in the FEDERAL REGISTER of October 21, 1969 (34 FR 17063). (c) The analytical methods used for detecting cyclamate in food are in sec tions 20.162–20.172 of the ‘‘Official Meth ods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by ref erence. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] § 189.140 Diethylpyrocarbonate (DEPC). (a) Diethylpyrocarbonate is the chemical pyrocarbonic acid diethyl ester, C6H10O5. It is a synthetic chem ical not found in natural products at levels detectable by available method ology and has been used as a ferment inhibitor in alcoholic and nonalcoholic beverages. (b) Food containing any added or de tectable level of DEPC is deemed to be adulterated in violation of the act VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00610 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 601 Food and Drug Administration, HHS § 189.165 based upon an order published in the FEDERAL REGISTER of August 2, 1972 (37 FR 15426). § 189.145 Dulcin. (a) Dulcin is the chemical 4 ethoxyphenylurea, C9H12N2O2. It is a synthetic chemical having a sweet taste about 250 times that of sucrose, is not found in natural products at levels detectable by the official methodology, and has been proposed for use as an ar tificial sweetener. (b) Food containing any added or de tectable level of dulcin is deemed to be adulterated in violation of the act, based upon an order published in the FEDERAL REGISTER of January 19, 1950 (15 FR 321). (c) The analytical methods used for detecting dulcin in food are in sections 20.173–20.176 of the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] § 189.155 Monochloroacetic acid. (a) Monochloroacetic acid is the chemical chloroacetic acid, C2H3C1O2. It is a synthetic chemical not found in natural products, and has been pro posed as a preservative in alcoholic and nonalcoholic beverages. Monochloroacetic acid is permitted in food package adhesives with an accept ed migration level up to 10 parts per billion (ppb) under § 175.105 of this chap ter. The official methods do not detect monochloroacetic acid at the 10 ppb level. (b) Food containing any added or de tectable level of monochloroacetic acid is deemed to be adulterated in viola tion of the act based upon trade cor respondence dated December 29, 1941 (TC–377). (c) The analytical methods used for detecting monochloroacetic acid in food are in sections 20.067–20.072 of the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is in corporated by reference. Copies may be obtained from the AOAC INTER NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989] § 189.165 Nordihydroguaiaretic acid (NDGA). (a) Nordihydroguaiaretic acid is the chemical 4,4′-(2,3-dimethyltetrame thylene) dipyrocatechol, C18H22O4. It occurs naturally in the resinous exudates of certain plants. The com mercial product, which is synthesized, has been used as an antioxidant in foods. (b) Food containing any added NDGA is deemed to be adulterated in viola tion of the act based upon an order published in the FEDERAL REGISTER of April 11, 1968 (33 FR 5619). (c) The analytical method used for detecting NDGA in food is in section 20.008(b) of the ‘‘Official Methods of Analysis of the AOAC INTER NATIONAL,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTER NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989] VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00611 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 602 21 CFR Ch. I (4–1–16 Edition) § 189.175 § 189.175 P–4000. (a) P–4000 is the chemical 5-nitro-2-n propoxyaniline, C9H12N2O3. It is a syn thetic chemical having a sweet taste about 4000 times that of sucrose, is not found in natural products at levels de tectable by the official methodology, and has been proposed for use as an ar tificial sweetener. (b) Food containing any added or de tectable level of P–4000 is deemed to be adulterated in violation of the act based upon an order published in the FEDERAL REGISTER of January 19, 1950 (15 FR 321). (c) The analytical methods used for detecting P–4000 in food are in sections 20.177–20.181 of the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989] § 189.180 Safrole. (a) Safrole is the chemical 4-allyl-1,2 methylenedioxy-benzene, C10H10O2. It is a natural constituent of the sassafras plant. Oil of sassafras is about 80 per cent safrole. Isosafrole and dihydrosafrole are derivatives of saf role, and have been used as flavoring compounds. (b) Food containing any added saf role, oil of sassafras, isosafrole, or dihydrosafrole, as such, or food con taining any safrole, oil of sassafras, isosafrole, or dihydrosafrole, e.g., sas safras bark, which is intended solely or primarily as a vehicle for imparting such substances to another food, e.g., sassafras tea, is deemed to be adulter ated in violation of the act based upon an order published in the FEDERAL REGISTER of December 3, 1960 (25 FR 12412). (c) The analytical method used for detecting safrole, isosafrole and dihydrosafrole is in the ‘‘Journal of the Association of Official Analytical Chemists,’’ Volume 54 (Number 4), pages 900 to 902, July 1971, which is in corporated by reference. Copies are available from the Office of Food Addi tive Safety (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1200, or available for inspection at the National Archives and Records Administration (NARA). For informa tion on the availability of this mate rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. [42 FR 14659, Mar. 15, 1977, as amended at 42 FR 56729, Oct. 28, 1977; 47 FR 11855, Mar. 19, 1982; 54 FR 24900, June 12, 1989; 78 FR 14667, Mar. 7, 2013] § 189.190 Thiourea. (a) Thiourea is the chemical thiocarbamide, CH4N2S. It is a syn thetic chemical, is not found in natural products at levels detectable by the of ficial methodology, and has been pro posed as an antimycotic for use in dip ping citrus. (b) Food containing any added or de tectable level of thiourea is deemed to be adulterated under the act. (c) The analytical methods used for detecting thiourea are in sections 20.115–20.126 of the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989] VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00612 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 603 Food and Drug Administration, HHS § 189.301 § 189.191 Chlorofluorocarbon propel lants. The use of chlorofluorocarbons in human food as propellants in self-pres surized containers is prohibited as pro vided by § 2.125 of this chapter. [43 FR 11317, Mar. 17, 1978] Subpart D—Substances Prohibited From Indirect Addition to Human Food Through Food Contact Surfaces SOURCE: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. Redesignated at 69 FR 42273, July 14, 2004. § 189.220 Flectol H. (a) Flectol H is the chemical 1,2 dihydro-2,2,4-trimethylquinoline, po lymerized, C12H15N. It is a synthetic chemical not found in natural prod ucts, and has been used as a component of food packaging adhesives. (b) Food containing any added or de tectable level of this substance is deemed to be adulterated in violation of the act based upon an order pub lished in the FEDERAL REGISTER of April 7, 1967 (32 FR 5675). [42 FR 14659, Mar. 15, 1977, as amended at 58 FR 17099, Apr. 1, 1993] § 189.240 Lead solders. (a) Lead solders are alloys of metals that include lead and are used in the construction of metal food cans. (b) Food packaged in any container that makes use of lead in can solder is deemed to be adulterated in violation of the Federal Food, Drug, and Cos metic Act, based upon an order pub lished in the FEDERAL REGISTER of June 27, 1995. [60 FR 33109, June 27, 1995] § 189.250 Mercaptoimidazoline and 2 mercaptoimidazoline. (a) Mercaptoimidazoline and 2 mercaptoimidazoline both have the molecular formula C3H6N2S. They are synthetic chemicals not found in nat ural products and have been used in the production of rubber articles that may come into contact with food. (b) Food containing any added or de lectable levels of these substances is deemed to be adulterated in violation of the act based upon an order pub lished in the FEDERAL REGISTER of No vember 30, 1973 (38 FR 33072). § 189.280 4,4′-Methylenebis (2-chloro analine). (a) 4,4′-Methylenebis (2 chloroanaline) has the molecular for mula, C13H12Cl2N2. It is a synthetic chemical not found in natural products and has been used as a polyurethane curing agent and as a component of food packaging adhesives and poly urethane resins. (b) Food containing any added or de tectable level of this substance is deemed to be adulterated in violation of the act based upon an order pub lished in the FEDERAL REGISTER of De cember 2, 1969 (34 FR 19073). § 189.300 Hydrogenated 4,4′-isopropyl idene-diphenolphosphite ester res ins. (a) Hydrogenated 4,4′-isopropylidene diphenolphosphite ester resins are the condensation product of 1 mole of triphenyl phosphite and 1.5 moles of hydrogenated 4,4′-isopropylidene diphenol such that the finished resins have a molecular weight in the range of 2,400 to 3,000. They are synthetic chemicals not found in natural prod ucts and have been used as anti oxidants and as stabilizers in vinyl chloride polymer resins when such polymer resins are used in the manu facture of rigid vinyl chloride polymer bottles. (b) Food containing any added or de tectable levels of these substances is deemed to be adulterated and in viola tion of the Federal Food, Drug, and Cosmetic Act, based upon an order pub lished in the FEDERAL REGISTER of Sep tember 9, 1987 (52 FR 33929). [54 FR 7188, Feb. 17, 1989] § 189.301 Tin-coated lead foil capsules for wine bottles. (a) Tin-coated lead foil is composed of a lead foil coated on one or both sides with a thin layer of tin. Tin-coat ed lead foil has been used as a capsule (i.e., as a covering applied over the cork and neck areas) on wine bottles to prevent insect infestation, as a barrier to oxygen, and for decorative purposes. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00613 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 604 21 CFR Ch. I (4–1–16 Edition) Pt. 190 Information received by the Food and Drug Administration establishes that the use of such a capsule on wine bot tles may reasonably be expected to re sult in lead becoming a component of the wine. (b) The capping of any bottles of wine after February 8, 1996, with a tin-coat ed lead foil capsule renders the wine adulterated and in violation of section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act because lead from the capsule, which is an unsafe food ad ditive within the meaning of section 409 of the act, may reasonably be ex pected to become a component of the wine. [61 FR 4820, Feb. 8, 1996] PART 190—DIETARY SUPPLEMENTS Subpart A [Reserved] Subpart B—New Dietary Ingredient Notification Sec. 190.6 Requirement for premarket notifica tion. AUTHORITY: Secs. 201(ff), 301, 402, 413, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff), 331, 342, 350b, 371). SOURCE: 62 FR 49891, Sept. 23, 1997, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 190 appear at 66 FR 56035, Nov. 6, 2001. Subpart A [Reserved] Subpart B—New Dietary Ingredient Notification § 190.6 Requirement for premarket no tification. (a) At least 75 days before intro ducing or delivering for introduction into interstate commerce a dietary supplement that contains a new die tary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered, the manufacturer or distributor of that supplement, or of the new dietary in gredient, shall submit to the Office of Nutritional Products, Labeling and Di etary Supplements (HFS–820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, information including any cita tion to published articles that is the basis on which the manufacturer or distributor has concluded that a die tary supplement containing such die tary ingredient will reasonably be ex pected to be safe. An original and two copies of this notification shall be sub mitted. (b) The notification required by para graph (a) of this section shall include: (1) The name and complete address of the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient; (2) The name of the new dietary in gredient that is the subject of the pre market notification, including the Latin binomial name (including the au thor) of any herb or other botanical; (3) A description of the dietary sup plement or dietary supplements that contain the new dietary ingredient in cluding: (i) The level of the new dietary ingre dient in the dietary supplement; and (ii) The conditions of use rec ommended or suggested in the labeling of the dietary supplement, or if no con ditions of use are recommended or sug gested in the labeling of the dietary supplement, the ordinary conditions of use of the supplement; (4) The history of use or other evi dence of safety establishing that the dietary ingredient, when used under the conditions recommended or sug gested in the labeling of the dietary supplement, will reasonably be ex pected to be safe, including any cita tion to published articles or other evi dence that is the basis on which the distributor or manufacturer of the die tary supplement that contains the new dietary ingredient has concluded that the new dietary supplement will rea sonably be expected to be safe. Any ref erence to published information offered in support of the notification shall be accompanied by reprints or photostatic copies of such references. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation; and VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00614 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