Title 21--FOOD AND DRUGS
Chapter I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN


Subpart A_General Provisions Sec. 1.1 General. 1.3 Definitions. 1.4 Authority citations. Subpart B_General Labeling...


printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in...


its regulations, the Food and Drug Administration includes a centralized citation of all of the statutory provisions that provide authority for any regulation that is included...


The term package means any container or wrapping in which any food, drug, device, or cosmetic is enclosed for use in the delivery or display of such commodities to...


(a) Labeling of a food, drug, device, or cosmetic shall be deemed to be misleading if it fails to reveal facts that are: (1) Material in light of other representations made...


from required label statements. Section 403(e) of the act (in this part 1, the term act means the Federal Food, Drug, and Cosmetic Act) provides for...


The following exemptions are granted from label statements required by this part: (a) Foods. (1) While held for sale, a food shall be exempt from the...


regulations prescribed under section 801(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act: (a) The term owner or consignee means the person who has the rights of...


an article offered for import has been requested by the district director, the collector of customs having jurisdiction over the article shall give to the owner or consignee...


Administration will pay for all import samples which are found to be in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act. Billing for reimbursement...


(a) If it appears that the article may be subject to refusal of admission, the district director shall give the owner or consignee a written notice to that effect, stating the...


Application for authorization to relabel or perform other action to bring the article into compliance with the act or to render it other than a food, drug, device...


(a) When authorization contemplated by Sec. 1.95 is granted, the district director shall notify the applicant in writing, specifying: (1) The procedure to...


801(b) of the act may be executed by the owner or consignee on the appropriate form of a customs single-entry or term bond, containing a condition for the redelivery of...


reconditioning inadmissible imports. The cost of supervising the relabeling or other action in connection with an [[Page 14]] import of food,...


(a) Scope. This section pertains to notifications and records required for human drug, biological product, device, animal drug, food, and cosmetic exports under sections 801 or 802...


Source: 68 FR 58960, Oct. 10, 2003, unless otherwise noted. General Provisions (a) You must register your facility under this...


subpart? This subpart does not apply to the following facilities: (a) A foreign facility, if food from such facility undergoes further...


(a) The act means the Federal Food, Drug, and Cosmetic Act. (b) In addition, for the purposes of this subpart: (1) Calendar day means every day shown on...


The owner, operator, or agent in charge of a facility that manufactures/processes, packs or holds food for consumption in the United States must register the facility no later...


(a) Electronic registration. (1) To register electronically, you must register at http://www.fda.gov/furls, which is available for registration 24 hours a day, 7 days a week....


Each registrant must submit the following information through one of the methods described in Sec. 1.231: (a) The name, full address, and phone number of...


registration form? FDA encourages, but does not require, you to submit the following items in your facility's registration. These data will enable FDA to communicate...


information? (a) Update requirements. The owner, operator, or agent in charge must submit an update to a facility's registration within 60...


information? (a) Notification of registration cancellation. A facility canceling its registration must do so within 60 calendar days of the reason...


In addition to the requirements of this subpart, you must comply with the registration regulations found in part 108 of this chapter, related to emergency permit...


register, update, or cancel your registration? (a) Section 301 of the act (21 U.S.C. 331) prohibits the doing of certain acts or causing such acts to be done. Under...


mean? Assignment of a registration number to a facility means that the facility is registered with FDA. Assignment of a registration number does not in any way...


the public? (a) The list of registered facilities and registration documents submitted under this subpart are not subject to disclosure under 5 U.S.C. 552 (the...


Source: 68 FR 59070, Oct. 10, 2003, unless otherwise noted. General Provisions (a) The act means the Federal Food, Drug,...


(a) This subpart applies to all food for humans and other animals that is imported or offered for import into the United States for use, storage, or distribution in the...


A prior notice for an article of food may be submitted by any person with knowledge of the required information. This person is the submitter. The submitter also may...


(a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must be confirmed by FDA for review...


(a) You must submit the prior notice electronically to FDA. You must submit all prior notice information in the English language, except that an individual's name, the name of...


(a) General. For each article of food that is imported or offered for import into the United States, except by international mail, you must submit the information...


you have received confirmation of a prior notice from FDA? (a)(1) If any of the information required in Sec. 1.281(a) except the information required in: (i)...


offered for import without adequate prior notice? (a) For each article of food that is imported or offered for import into the United States, except for food arriving...


submit adequate prior notice or otherwise failing to comply with this subpart? (a) The importing or offering for import into the United States of an article of food...


offered for import from unregistered facilities that are required to register under 21 CFR part 1, subpart H? (a) If an article of food from a foreign...


Subpart A_General Provisions Sec. 2.5 Imminent hazard to the public health. 2.10 Examination and investigation...


(a)(1) When any officer or employee of the Department collects a sample of a food, drug, or cosmetic for analysis under the act, the sample shall be designated as...


method of analysis is not prescribed in a regulation, it is the policy of the Food and Drug Administration in its enforcement programs to utilize the methods of analysis of...


color identification to prevent adulteration of human and animal food. (a) In recent years there has developed increasing use of poisonous treatments...


shipment or storage of food and animal feed. (a) Investigations by the Food and Drug Administration, the National Communicable Disease Center of the U.S. Public...


Poison Act. For the purpose of determining whether an article containing ammonia is subject to the Federal Caustic Poison Act, the ammonia content is to...


and Cosmetic Act Sec. 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. (a) As used in this section,...


Purpose. Subpart A_Assignment of Agency Component for Review of Premarket Applications Sec. 3.1...


Definitions. For the purpose of this part: (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) Agency component means the Center for Biologics...


Scope. This section applies to: (a) Any combination product, or (b) Any product where the agency component with primary jurisdiction is unclear or...


Designated agency component. (a) To designate the agency component with primary jurisdiction for the premarket review and regulation of a combination product, the...


Procedures for identifying the designated agency component. (a)(1) The Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and...


Product jurisdiction officer. The Office of Combination Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD...


Request for designation. (a) Who should file: the sponsor of: (1) Any combination product the sponsor believes is not covered by an intercenter agreement; or ...


Letter of designation. (a) Each request for designation will be reviewed for completeness within 5 working days of receipt. Any request [[Page...


Effect of letter of designation. (a) The letter of designation constitutes an agency determination that is subject to change only as provided in paragraph (b) of...


Stay of review time. Any filing with or review by the product jurisdiction officer stays the review clock or other established time periods for agency action for...


Secretary of Health and Human Services to the Commissioner of Food and Drugs. Subpart A_Delegations of Authority to the Commissioner of Food...


(a) Notwithstanding provisions of Sec. 5.10 or any previous delegations of authority to the contrary, the Secretary of Health and Human Services (Secretary)...


the Commissioner to other officers of the Food and Drug Administration. (a) Final authority of the Commissioner of Food and Drugs (Commissioner)...


(a) Each Regional Food and Drug Director is authorized, during any period when normal channels of direction are disrupted between the Food and Drug Administration headquarters and...


use of Department seal. (a) The following officials are authorized to certify true copies of, or extracts from, any books, records, papers, or other documents on...


authorization of testimony. (a) The following officials are authorized to make determinations to disclose official records and information under part 20 of this...


(a) The Associate Commissioner for Regulatory Affairs is authorized to perform the functions of the Commissioner of Food and Drugs as requested by the...


and health information and promotion programs. (a) The following officials are authorized under sections 301, 307, 311, 1701, 1702, 1703, and 1704 of the...


(a) Under authority of sections 207(g) and 208(f) of the PHS Act (42 U.S.C. 209(g) and 210(f)), and within the limits of an approved service fellowship plan, the following...


products, medical devices, and food and color additives; and authority to perform due diligence determinations and informal hearings. (a) The Deputy...


following officials are authorized to designate officials to hold informal hearings that relate to their assigned functions under sections 305, 404(b), and 801(a) of the Federal...


(a) For drugs assigned to their organizations, the following officials are authorized to grant or deny citizen petitions submitted under Sec. 10.30 of this chapter for a stay...


members for advisory committees and authority to sign conflict of interest waivers. (a) Each Center director is authorized to select members of, and consultants...


(a) Designated officers and employees of the Food and Drug Administration who have been issued the Food and Drug Administration official credentials consisting of Form...


Regional Food and Drug Directors and District Directors are authorized to issue certificates of sanitation under Sec. 1240.20 of this chapter. These officials may...


(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under section 309 of the...


and orders for debarment and denial of an application to terminate debarment. (a) The Director, the Deputy Director, and the Associate Director for...


under 5 U.S.C. 605(b) for any proposed and final rules. (a) The following officials are authorized to perform all the functions of the Commissioner of Food...


provisions of the Drug Amendments of 1962. The Director, the Deputy Director, and the Directors, Office of Review Management and Office of...


new drugs for investigational use in human beings. (a) The following officials, for drugs under their jurisdiction, are authorized to perform all the functions of...


withdraw approval of a charge for investigational new drugs. (a) The following officials, for drugs under their jurisdiction, are authorized to perform all the functions...


their supplements. (a)(1) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with...


temporary scheduling notices. The Director, Center for Drug Evaluation and Research (CDER) and the Director, Executive Operations Staff, Office of...


proposals to refuse approval or to withdraw approval of new drug applications and their supplements. (a) The Director, the Deputy Director, and the Directors, Office...


dates for abbreviated new drug applications and certain new drug applications. (a) The following officials are authorized to perform all of the functions of...


for compliance with certain labeling requirements for human prescription drugs. (a) The following officials are authorized to extend or stay an effective date...


or reductions of prescription drug user fees. The Director, Center for Drug Evaluation and Research (CDER), and the Associate Director for Regulatory Policy, CDER,...


patent information, current good manufacturing practices and false or misleading labeling of new drugs. (a) The following officials are authorized to...


vaccines. (a) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER) are authorized to perform the functions of the Commissioner...


Biologics Evaluation and Research Director's program authorities. (a) The following officials are authorized to perform all the functions of the Director, Center...


a hearing on proposals for denial of approval of applications for licenses, suspension of licenses, or revocation of licenses and certain notices of revocation of ...


for the propagation or manufacture and preparation of biological products. (a) The following officials are authorized to issue licenses under section 351 of the...


of biological products. (a) The following officials are authorized to issue written notices of release for distribution of licensed biological products...


generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims. (a)(1) The following officials...


permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption. (a) The Director and Deputy...


and related products. The Regional Food and Drug Directors and District Directors are authorized to perform and to designate other officials to perform all of...


approving accrediting bodies under the National Laboratory Accreditation Program. The Director, Deputy Director, and Director of Regulations and Policy, Center for...


instruction. (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under...


5.400 Issuance of Federal Register documents to recognize or to withdraw recognition of a standard to meet premarket submission requirements. ...


Authority Sec. 5.401 Issuance of Federal Register documents pertaining to exemptions from premarket notification. (a) The Director and Deputy Directors for Science...


5.402 Detention of adulterated or misbranded medical devices. (a) The following officials are authorized to perform all the functions of the Commissioner...


5.403 Authorization to use alternative evidence for determination of the effectiveness of medical devices. (a) The following officials, for medical...


5.404 Notification to petitioners of determinations made on petitions for reclassification of medical devices. (a) The following officials, for...


5.405 Determination of classification of devices. (a) The following officials, for devices assigned to their respective organizations, are authorized...


5.406 Notification to sponsors of deficiencies in petitions for reclassification of medical devices. (a) The following officials, for medical...


Authority Sec. 5.407 Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for...


5.408 Determinations concerning the type of valid scientific evidence submitted in a premarket approval application. (a) The following officials...


5.409 Determinations that medical devices present unreasonable risk of substantial harm. (a) The following officials, for medical devices assigned to...


5.410 Orders to repair or replace, or make refunds for, medical devices. (a) The following officials, for medical devices assigned to their...


5.411 Medical device recall authority. (a) The following officials, for medical devices assigned to their respective organizations, are authorized to...


5.412 Temporary suspension of a medical device application. (a) The following officials for medical devices assigned to their respective organizations...


Authority Sec. 5.413 Approval, disapproval, or withdrawal of approval of applications and entering into agreements for investigational device exemptions. ...


Authority Sec. 5.414 Postmarket surveillance. (a) For any class II or class III device (including any device that is or contains a drug or biologic), the failure...


5.415 Authority relating to medical device reporting procedures. (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center...


5.416 Medical device tracking. (a) The following officials are authorized to issue orders under section 519(e) of the Federal Food, Drug, and Cosmetic...


Authority Sec. 5.417 Authority pertaining to accreditation functions for medical devices. (a) The following officials are authorized under section 523(a)(1)...


pertaining to the determination of safe levels, notice of need for development of an analytical method, notice of availability of a developed analytical...


medicated feed mill license applications and their supplements. (a) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized...


orders relating to new animal drugs and medicated feed mill license applications. (a) The Director and Deputy Director, Center for Veterinary Medicine (CVM),...


dates for abbreviated new animal drug applications and certain new animal drug applications. (a) The following officials are authorized to perform all the...


patent information, current good manufacturing practices and false or misleading labeling of new animal drugs and feeds bearing or containing new animal drugs. ...


new drugs for investigational use in animals. (a) The following officials are authorized to perform all functions of the Commissioner of Food and Drugs with regard to...


for electronic products. (a) The following officials are authorized to grant and withdraw variances and issue notices of availability of any approved variance...


from performance standards and prohibited acts. (a) The following officials are authorized to exempt from performance standards any electronic product intended...


certification and identification for electronic products. (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices...


and repair or replacement of, electronic products. (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices...


provide data to ultimate purchasers of electronic products. (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices...


to provide data to manufacturers of electronic products. (a) The Director and Deputy Director for Science and for Regulations and Policy, Center for Devices...


State and Local authorities for enforcement of radiation control legislation and regulations. (a) The Director and Deputy Directors, Center for Devices and...


of product primary jurisdiction. The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of the Senior Associate Commissioner, Office of...


a product that is or contains a biologic, a device, or a drug. (a) For a product that is or contains a biologic, a device, or a drug, the following officials in the...


(a) The Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized, under section 801 of the Federal Food, Drug,...


(a) The following officials are authorized, under section 802(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382(b)(2) and (b)(3)),...


agents. The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH) and the Director and...


(a) The Director, Office of Orphan Products Development (OPD), Office of the Senior Associate Commissioner (OSAC), Office of the Commissioner (OC), is authorized to...


mammography facilities meet quality standards. (a) The following officials are authorized to ensure mammography facilities obtain certificates under...


organization of the Food and Drug Administration consists of the following: Office of...


[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR5.1105] [Page 96] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 5_DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents Subpart M_Organization Sec. 5.1105 Chief Counsel, Food and Drug Administration. The Office of the Chief Counsel's mailing address is 5600 Fishers Lane, rm. 6-57, Rockville, MD 20857. ...


(a) Division of Dockets Management (HFA-305). The Division of Dockets Management Public Room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD...


NORTHEAST REGION Regional Field Office: 158-15 Liberty Ave., Jamaica, NY 11433. Northeast Regional Laboratory: 158-15 Liberty Ave., Jamaica,...


Provisions Sec. 7.1 Scope. 7.3 Definitions. 7.12 Guaranty. 7.13 Suggested forms of guaranty. Subpart B [Reserved] Subpart C_Recalls...


(b) Citation or cite means a document and any attachments thereto that provide notice to a person against whom criminal prosecution is contemplated of...


[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR7.12] [Page 99] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 7_ENFORCEMENT POLICY--Table of Contents Subpart A_General Provisions Sec. 7.12 Guaranty. In case of the giving of a guaranty or undertaking referred to in section 303(c)(2) or (3) of the act, each person signing such guaranty or undertaking shall be considered to have given it. ...


undertaking referred to in section 303(c)(2) of the act may be: (1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or...


7.40 Recall policy. Source: 43 FR 26218, June 16, 1978, unless otherwise noted. (a) Recall is an effective method of removing or correcting...


7.41 Health hazard evaluation and recall classification. (a) An evaluation of the health hazard presented by a product being recalled or considered for...


7.42 Recall strategy. (a) General. (1) A recall strategy that takes into account the following factors will be developed by the agency for a Food and...


7.45 Food and Drug Administration-requested recall. (a) The Commissioner of Food and Drugs or his designee under Sec. 5.20 of this chapter may request a firm...


7.46 Firm-initiated recall. (a) A firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm...


7.49 Recall communications. (a) General. A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The...


7.50 Public notification of recall. The Food and Drug Administration will promptly make available to the public in the weekly FDA Enforcement Report...


7.53 Recall status reports. (a) The recalling firm is requested to submit periodic recall status reports to the appropriate Food and Drug Administration...


7.55 Termination of a recall. (a) A recall will be terminated when the Food and Drug Administration determines that all reasonable efforts have been made...


7.59 General industry guidance. A recall can be disruptive of a firm's operation and business, but there are several steps a prudent firm can take in...


(a)(1) Except as provided in paragraph (a) (2) and (3) of this section, a person against whom criminal prosecution under the Federal Food, Drug,...


(a) The presentation of views shall be heard by a designated Food and Drug Administration employee. Other Food [[Page 106]] and...


before report of criminal violation. (a) Records related to a section 305 opportunity for presentation of views constitute investigatory...


Subpart A_General Provisions Sec. 10.1 Scope. 10.3 Definitions. 10.10 Summaries of administrative practices and procedures. 10.19 Waiver, suspension,...


definitions apply in this part and parts 12, 13, 14, 15, 16, and 19: Act means the Federal Food, Drug, and Cosmetic Act unless otherwise indicated. ...


procedures. To encourage public participation in all agency activities, the Commissioner will prepare for public distribution summaries of FDA administrative...


procedural requirements. The Commissioner or a presiding officer may, either voluntarily or at the request of a participant, waive, suspend, or modify any provision in...


Division of Dockets Management; computation of time; availability for public disclosure. (a) A submission to the Division of Dockets Management of a petition,...


An administrative proceeding may be initiated in the following three ways: (a) An interested person may petition the Commissioner to issue, amend,...


(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this...


action. (a) The Commissioner may at any time reconsider a matter, on the Commissioner's own initiative or on the petition of an interested person. (b)...


(a) The Commissioner may at any time stay or extend the effective date of an action pending or following a decision on any matter. (b) An interested person...


the efficient enforcement of the law. (a) The Commissioner may propose and promulgate regulations for the efficient enforcement of the laws administered by FDA...


exhaustion of administrative remedies. (a) This section applies to court review of final administrative action taken by the Commissioner, including...


orders after an opportunity for a formal evidentiary public hearing. (a) The Commissioner shall promulgate regulations and orders after an opportunity for a...


parte communications. (a) This section applies to any matter subject by statute to an opportunity for a formal evidentiary public hearing, as listed in Sec. 10.50(c),...


(a) This section applies when a Federal, State, or local court holds in abeyance, or refers to the Commissioner, any matter for an initial administrative determination under...


(a) In addition to public hearings and proceedings established under this part and other sections of this chapter, meetings may be held and correspondence may be...


in administrative file. (a) This section applies to every significant FDA decision on any matter under the laws administered by the Commissioner, whether it...


(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the...


notices and regulations. (a) A representative of FDA may discuss orally or in writing with an interested person ideas and recommendations for notices or...


(a) An interested person may request an advisory opinion from the Commissioner on a matter of general applicability. (1) The request will be granted whenever feasible. ...


recommendations, and agreements. (a) Regulations. FDA regulations are promulgated in the Federal Register under Sec. 10.40 or Sec. 10.50 and codified in the...


activities. (a) General. This section applies to participation by FDA employees in standard-setting activities outside the agency. Standard-setting...


(a) Public calendar. A public calendar will be prepared and made publicly available by FDA each week showing, to the extent feasible, significant events of the previous...


(a) An organization may represent its members by filing petitions, comments, and objections, and otherwise participating in an administrative proceeding subject...


At any time in the course of a proceeding subject to this part, a person may propose settlement of the issues involved. A participant in a proceeding will have an opportunity...


(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents. ...


Policy and Procedures Sec. 10.200 Scope. Source: 49 FR 14726, Apr. 13, 1984, unless otherwise noted. This guideline describes FDA's policy and...


Policy and Procedures Sec. 10.203 Definitions. (a) Public administrative proceeding as used in this guideline means any FDA proceeding which the public has a right...


Policy and Procedures Sec. 10.204 General. (a) FDA has for many years willingly committed itself to a policy of openness. In many instances FDA has sought to...


Policy and Procedures Sec. 10.205 Electronic media coverage of public administrative proceedings. (a) A person may record electronically any open...


Policy and Procedures Sec. 10.206 Procedures for electronic media coverage of agency public administrative proceedings. (a) To facilitate the agency's response...


Subpart A_General Provisions Sec. 11.1 Scope. 11.2 Implementation. 11.3 Definitions. Subpart...


required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional...


and interpretations of terms contained in section 201 of the act apply to those terms when used in this part. (b) The following definitions of terms also apply to...


Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the...


Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and,...


(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer; (2)...


Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be...


(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. (b) Before an organization establishes,...


controls. (a) Electronic signatures that are not based upon biometrics shall: (1) Employ at least two distinct identification components such as an...


Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security...


Subpart A_General Provisions Sec. 12.1 Scope. Subpart B_Initiation of Proceedings 12.20 Initiation of a hearing involving the...


amendment, or revocation of a regulation. (a) A proceeding under section 409(f), 502(n), 512(n)(5), 701(e), or 721(d) of the act or section 4 or 5 of the...


issuance, amendment, or revocation of an order. (a) A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3) or (4), of section 515(g)(1) of the act, or...


a regulation or order. (a) Objections and requests for a hearing under Sec. 12.20(d) must be submitted to the Division of Dockets Management and will be...


As soon as practicable after the expiration of the time for filing objections to and requests for hearing on agency action involving the issuance, amendment, or revocation of...


(a) As soon as possible the Commissioner will review all objections and requests for hearing filed under Sec. 12.22 and determine-- (1) Whether the...


order. If the Commissioner determines upon review of an objection or request for hearing that the regulation or order should be modified or revoked, the...


If the Commissioner determines upon review of the objections or requests for hearing that a hearing is not justified, in whole or in part, a notice of the...


a regulation. (a) A person with a right to submit objections and a request for hearing under Sec. 12.20(d) may submit objections and waive the right to a hearing....


(a) A person with a right to request a hearing may waive that right and request one of the following alternatives: (1) A hearing before a Public Board of...


(a) If the Commissioner determines upon review of the objections and requests for hearing that a hearing is justified on any issue, the Commissioner will publish a notice...


(a) If no objections are filed and no hearing is requested on a regulation under Sec. 12.20(e), the regulation is effective on the date specified in the regulation...


(a) If a person who is subject to a notice of opportunity for hearing under Sec. 12.21(b) does not request a hearing, the Commissioner will-- (1) Publish a final...


has filed a notice of participation under Sec. 12.45 may appear in person or by counsel or other representative in any hearing and, subject to Sec. 12.89, may be heard...


(a) Within 30 days after publication of the notice of hearing under Sec. 12.35, a person desiring to participate in a hearing is to file with the Division of Dockets Management under...


(a) Designated agency contact. All inquiries from the public about scheduling, location, and general procedures should be addressed to the Deputy Commissioner...


in a hearing will be the Commissioner, a member of the Commissioner's office to whom the responsibility for the matter involved has been delegated, or an administrative...


[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR12.62] [Page 153] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 12_FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents Subpart D_Presiding Officer Sec. 12.62 Commencement of functions. The functions of the presiding officer begin upon designation and end upon the filing of the initial decision. ...


The presiding officer has all powers necessary to conduct a fair, expeditious, and orderly hearing, including the power to-- (a) Specify and change the date, time, and place...


(a) A participant may request the presiding officer to disqualify himself/herself and withdraw from the proceeding. The ruling on any such request may be appealed in...


(a) If the presiding officer is unable to act for any reason, the Commissioner will assign the powers and duties to another presiding officer. The substitution will not affect...


(a) Submissions, including pleadings in a hearing, are to be filed with the Division of Dockets Management under Sec. 10.20 except that only two copies need be filed....


(a) A participant who believes that compliance with the filing and service requirements of this section constitutes an unreasonable financial burden may submit to...


a hearing, a person may, under Sec. 10.85, request the Commissioner for an advisory opinion on whether any regulation or order under consideration in the proceeding applies to...


(a) Before the notice of hearing is published under Sec. 12.35, the director of the center responsible for the matters involved in the hearing shall submit...


proof. (a) The objective of a formal evidentiary hearing is the fair determination of relevant facts consistent with the right of all interested persons to participate...


(a) A nonparty participant may-- (1) Attend all conferences (including the prehearing conference), oral proceedings, and arguments; (2) Submit written testimony...


All participants in a hearing will conduct themselves with dignity and observe judicial standards of practice and ethics. They may not indulge in personal attacks,...


A prehearing conference will commence at the date, time, and place announced in the notice of hearing, or in a later notice, or as specified by the presiding officer in a...


(a) Participants in a hearing are to appear at the prehearing conference prepared to discuss and resolve all matters specified in paragraph (b) of this section. (1)...


hearing commences, a participant may move, with or without supporting affidavits, for a summary decision on any issue in the hearing. Any other participant may, within 10 days...


hearing consists of the development of evidence and the resolution of factual issues as set forth in this subpart and in the prehearing order. [[Page 159]] (b)...


may be taken of such matters as might be judicially noticed by the courts of the United States or of any other matter peculiarly within the general knowledge of FDA as an...


after the taking of evidence is completed, the presiding officer will announce a schedule for the filing of briefs. Briefs are to be filed ordinarily within 45 days of the...


(a) Except as provided in paragraph (b) of this section and in Sec. Sec. 12.35(b), 12.45(e), 12.93(f), and 12.99(d), when an interlocutory appeal is...


officer will arrange for a verbatim stenographic transcript of oral testimony and for necessary copies of the transcript. (b) One copy of the transcript will be placed...


relating to the proceeding is to be filed under Sec. 12.80, and must include a draft order, except one made in the course of an oral hearing before the presiding officer. ...


(a) The record of a hearing consists of-- (1) The order or regulation or notice of opportunity for hearing that gave rise to the hearing; (2) All...


the record will be publicly available in accordance with Sec. 10.20(j). Documents available for examination or copying will be placed on public display in the office of...


(a) The presiding officer shall prepare and file an initial decision as soon as possible after the filing of briefs and oral argument. (b) The initial decision must contain-- ...


(a) A participant may appeal an initial decision to the Commissioner by filing exceptions with the Division of Dockets Management, and serving them on the...


review of initial decision. (a) On appeal from or review of the initial decision, the Commissioner has all the powers given to make the initial decision. On...


Following notice or publication of the final decisions, a participant may petition the Commissioner for reconsideration of any part or all of the decision under Sec. 10.33...


Commissioner's final decision constitutes final agency action from which a participant may petition for judicial review under the statutes governing the matter involved....


The Chief Counsel for FDA has been designated by the Secretary as the officer on whom copies of petitions of judicial review are to be served. This officer is responsible...


Subpart A_General Provisions Sec. 13.1 Scope. 13.5 Notice of a hearing before a Board. 13.10 Members of a Board. 13.15 Separation of functions;...


If the Commissioner determines that a Board should be established to conduct a hearing on any matter, a notice of hearing will be published in the Federal...


(a) All members of a Board are to have medical, technical, scientific, or other qualifications relevant to the issues to be considered, are subject to the conflict of...


communications; administrative support. (a) The proceeding of a Board are subject to the provisions of Sec. 10.55 relating to separation of functions and ex...


(a) Submissions are to be filed with the Division of Dockets Management under Sec. 10.20. (b) The person making a submission shall serve copies of it on...


the participants. (a) Before the notice of hearing is published under Sec. 13.5, the director of the center responsible for the matters involved in the hearing...


(a) The purpose of a Board is to review medical, scientific, and technical issues fairly and expeditiously. The proceedings of a Board are conducted as a scientific...


a Board. (a) The administrative record of a hearing before a Board consists of the following: (1) All relevant Federal Register notices. (2)...


(a) The availability for public examination and copying of each document which is a part of the administrative record of the hearing is governed by...


[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR13.50] [Page 167] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 13_PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY--Table of Contents Subpart C_Records of a Hearing Before a Board Sec. 13.50 Record for administrative decision. The administrative record of the hearing specified in Sec. 13.40(a) constitutes the exclusive record for decision. ...


Subpart A_General Provisions. Sec. 14.1 Scope. 14.5 Purpose of proceedings before an advisory committee. 14.7 Administrative...


an advisory committee. (a) An advisory committee is utilized to conduct public hearings on matters of importance that come before FDA, to review the issues involved,...


A person who alleges noncompliance by the Commissioner or an advisory committee with any provision of this part or the Federal Advisory Committee Act may pursue the...


This part applies to Congress, individual Members of Congress, and other employees or representatives of Congress in the same way that they apply to any other member...


a contract with FDA. (a) FDA may enter into contracts with independent scientific or technical organizations to obtain advice and recommendations on particular...


an advisory committee. (a) Before the first of each month, and at least 15 days in advance of a meeting, the Commissioner will publish a notice in the...


(a) No advisory committee may conduct a meeting except at the call or with the advance approval of, and with an agenda approved by, the designated...


meetings. An advisory committee meeting has the following portions: (a) The open public hearing. Every committee meeting includes an open portion,...


portions of advisory committee meetings. (a) No committee meeting may be entirely closed. A portion of a meeting may be closed only in accordance with a written...


an advisory committee. (a) For each meeting, the open portion for public participation, which constitutes a public hearing under Sec. 14.25(a), will be at least 1...


(a) The advisory committee chairman has the authority to conduct hearings and meetings, including the authority to adjourn a hearing or meeting if the...


with other persons. (a) A committee may confer with any person who may have information or views relevant to any matter pending before the committee. (b)...


members of an advisory committee. The Commissioner shall prepare and provide to all committee members a compilation of materials bearing upon members' duties...


advisory committee. (a) Ten copies of written submissions to a committee are to be sent to the executive secretary unless an applicable Federal Register notice or...


particular advisory committee. (a) In addition to these rules, an advisory committee may, with the concurrence of the designated Federal employee, adopt additional...


renewal of advisory committees. (a) An advisory committee may be established or renewed whenever it is necessary or appropriate for the committee to hold a...


advisory committees. (a) Except as provided in paragraph (c) of this section, a standing advisory committee is terminated when it is no longer needed, or not later...


and reports of advisory committee meetings. (a) The executive secretary or other designated agency employee prepares detailed minutes of all advisory...


Transcripts of advisory committee meetings. (a) The agency will arrange for a transcript or recording to be made for each portion of a meeting. (b) A transcript...


inquiries and requests for advisory committee records. (a) Public inquiries on general committee matters, except requests for records, are to be directed to:...


record of a public hearing before an advisory committee. (a) Advice or recommendations of an advisory committee may be given only on matters covered in...


Examination of administrative record and other advisory committee records. (a) The administrative record and other committee records are available for public...


members of standing policy and technical advisory committees. (a) Members of a policy advisory committee-- (1) Shall have diverse interests,...


members of standing advisory committees. (a) The Commissioner will publish one or more notices in the Federal Register each year requesting nominations for voting members...


selection of nonvoting members of standing technical advisory committees. (a) This section applies when the Commissioner concludes that a technical advisory...


of nonvoting members of advisory committees. (a) A nonvoting member of an advisory committee selected to represent and serve as a liaison with...


members. In selecting members of an ad hoc advisory committee, the Commissioner may use the procedures in Sec. Sec. 14.82 and 14.84 or any other procedure...


advisory committee members. (a)(1) Except as provided in paragraphs (a) (2) and (3) of this section, all voting advisory committee members shall, and nonvoting...


committees. Standing advisory committees and the dates of their establishment are as follows: (a) Office of the Commissioner--(1) Board of...


Committee Sec. 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical...


Committee Sec. 14.122 Functions of TEPRSSC. (a) In performing its function of advising the Commissioner, TEPRSSC-- (1) May propose...


Committee Sec. 14.125 Procedures of TEPRSSC. (a) When the Commissioner is considering promulgation of a performance standard for an electronic product,...


Committee Sec. 14.127 Membership of TEPRSSC. (a) The Commissioner will appoint the members after consultation with public and private...


Committee Sec. 14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records. (a) In accordance with 42 U.S.C. 263f(f)(1)(B), all proceedings...


a color additive advisory committee. The Commissioner will establish a color additive advisory committee under the following circumstances: (a) The...


color additive advisory committee. (a) A color additive advisory committee reviews all available information relating to the matter referred to it, including...


a color additive advisory committee. (a) A color additive advisory committee is subject to all the requirements of the Federal Advisory Committee Act and this part. ...


a color additive advisory committee. (a) The members of a color additive advisory committee are selected in the following manner: (1) If a color additive...


to a color additive advisory committee. (a) When a matter is referred to a color additive advisory committee, all related costs, including...


standing technical advisory committees for human prescription drugs. The standing technical advisory committees for human prescription drugs are...


of an advisory committee on the initiative of FDA. (a) Any matter involving a human prescription drug under review within the agency may, in the discretion of...


an advisory committee at the request of an interested person. Any interested person may request, under Sec. 10.30, that a specific matter relating to a...


and recommendations in writing. Advice and recommendations given by a committee on a specific drug or a class of drugs are ordinarily in...


Subpart A_General Provisions Sec. 15.1 Scope. Subpart B_Procedures for Public Hearing Before the Commissioner 15.20 Notice of a public hearing...


before the Commissioner. (a) If the Commissioner determines that a public hearing should be held on a matter, the Commissioner will publish a notice of hearing...


for hearing. (a) The notice of hearing will provide persons an opportunity to file a written notice of participation with the Division of Dockets...


A person may submit information or views on the subject of the hearing in writing to the Division of Dockets Management, under Sec. 10.20. The record of the hearing...


before the Commissioner. (a) The Commissioner or a designee may preside at the hearing, except where a regulation provides that the Commissioner will...


(a) The administrative record of a public hearing before the Commissioner consists of the following: (1) All relevant Federal Register notices, including...


Section 10.20(j) governs the availability for public examination and copying of each document in the administrative record of...


Subpart A_General Provisions Sec. 16.1 Scope. 16.5 Inapplicability and limited applicability. ...


limited applicability. (a) This part does not apply to the following: (1) Informal presentation of views before reporting a criminal violation under section 305 of...


regulatory hearing. (a) A regulatory hearing is initiated by a notice of opportunity for hearing from FDA. The notice will-- (1) Be sent by mail, telegram,...


required by the act or a regulation. (a) A regulatory hearing required by the act or a regulation under Sec. 16.1(b) will be initiated in the same manner as...


and summary decision. (a) A request for a hearing may be denied, in whole or in part, if the Commissioner or the FDA official to whom the authority to make the...


Whenever the Commissioner has delegated authority under part 5 on a matter for which a regulatory hearing is available under this part, the functions of...


officer. (a) An FDA employee to whom the Commissioner delegates such authority, or any other agency employee designated by an employee to whom such authority...


presiding officer and Commissioner. (a) Regulatory hearings are not subject to the separation of functions rules in Sec. 10.55. (b) Those persons who...


procedure. (a) A regulatory hearing is public, except when the Commissioner determines that all or part of a hearing should be closed to prevent a...


[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR16.62] [Page 201] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 16_REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION --Table of Contents Subpart D_Procedures for Regulatory Hearing Sec. 16.62 Right to counsel. Any party to a hearing under this part has the right at all times to be advised and accompanied by counsel. ...


of a regulatory hearing. (a) The administrative record of the regulatory hearing consists of the following: (1) The notice of opportunity for...


administrative record. Part 20 governs the availability for public disclosure of each document that is a part of the administrative record of a...


decision and record for decision. (a) With respect to a regulatory hearing at the Commissioner's initiative under Sec. 16.1(a), the Commissioner shall consider...


stay of action. After any final administrative action that is the subject of a hearing under this part, any party may petition the Commissioner...


Section 10.45 governs the availability of judicial review concerning any regulatory action which is the subject of a hearing under...


complaint. 17.9 Answer. 17.11 Default upon failure to file an answer. 17.13 Notice of hearing. 17.15 Parties to the hearing. 17.17 Summary...


rise to civil money penalty actions brought under 21 U.S.C. 333(g)(1): (1) Significant departure, for the purpose of interpreting 21 U.S.C. 333(g)(1)(B)(i), means...


administrative civil money penalty actions by serving on the respondent(s) a complaint signed by the Office of the Chief Counsel attorney for the Center and by filing a copy of...


or similar mail delivery service with a return receipt record reflecting receipt; or (2) Delivery in person to: (i) An individual respondent; or (ii)...


Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, within 30 days of service of the complaint. Unless stated otherwise, an...


time prescribed in Sec. 17.9 and if service has been effected as provided in Sec. 17.7, the presiding officer shall assume the facts alleged in the complaint to be true,...


the respondent. Such notice shall include: (a) The date, time, and place of a prehearing conference, if any, or the date, time, and place of the hearing if there is not to be...


jurisdiction over the matter at issue. No other person may participate. (b) The parties may at any time prior to a final decision by the entity deciding any...


without supporting affidavits (which, for purposes of this part, shall include declarations under penalty of perjury), for a summary decision on any issue in the hearing....


this section, rulings of the presiding officer may not be appealed before consideration on appeal of the entire record of the hearing. (b) A ruling of the presiding officer...


avoid delay, maintain order, and assure that a record of the proceeding is made. (b) The presiding officer has the authority to: (1) Set and change the...


communicate in any way with the presiding officer on any matter at issue in a case, unless on notice and opportunity for all parties to participate. This provision does...


(b) Upon the motion of any party, the presiding officer shall schedule at least one prehearing conference at a reasonable time in advance of the hearing. ...


officer, a party may make a request to another party for production, inspection, and copying of documents that are relevant to the issues before the presiding...


hearing, or by such other time as is specified by the presiding officer, the parties shall exchange witness lists, copies of prior written statements of proposed witnesses,...


the hearing may, when authorized by law, request that the presiding officer issue a subpoena. (b) A subpoena requiring the attendance and testimony of an individual...


with respect to discovery sought by a party or with respect to the hearing, seeking to limit the availability or disclosure of evidence. (b) When issuing a...


subpoenaed in the amounts that would be payable to a witness in a proceeding in a United States District Court. A check for witness fees and mileage shall accompany the...


the time begins with the day following the act or event, and includes the last day of the period, unless either such day is a Saturday, Sunday, or Federal holiday,...


(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, shall include an original and two copies. (2) The first page of...


Motions shall state the relief sought, the authority relied upon, and the facts alleged, and shall be filed with the Division of Dockets Management (HFA-305), Food and...


determine whether the respondent is liable for a civil money penalty and, if so, the appropriate amount of any such civil money penalty considering any aggravating or...


civil money penalties and assessments, the presiding officer and the Commissioner of Food and Drugs or entity designated by the Commissioner to decide the appeal (currently...


(1) Failing to comply with an order, subpoena, rule, or procedure governing the proceeding; (2) Failing to prosecute or defend an action; or (3) Engaging in...


be given orally by witnesses under oath or affirmation. (b) Direct testimony shall be admitted in the form of a written declaration submitted under penalty of...


(b) Except as provided in this part, the presiding officer shall not be bound by the ``Federal Rules of Evidence.'' However, the presiding officer may apply the ``Federal Rules...


counsel have 30 days from the time the transcript becomes available to propose corrections in the transcript of oral testimony. Corrections are permitted only...


time for filing such briefs (which shall be filed simultaneously), which shall not exceed 60 days from the date the parties received the transcript of the hearing or, if...


administrative record. The decision shall contain findings of fact, conclusions of law, and the amount of any penalties and assessments imposed. (b) The findings of...


decision not to withdraw a default judgment, or a decision granting summary decision to the Commissioner of Food and Drugs or other entity the Commissioner designates to decide...


defect in any ruling or order or in any act done or omitted by the presiding officer or by any of the parties is grounds for vacating, modifying, or otherwise disturbing an...


the appeal (currently the DAB) constitutes final agency action from which a respondent may petition for judicial review under the statutes governing the matter...


delivered to the Director, Division of Financial Management (HFA-100), Food and Drug Administration, rm. 11-61, 5600 Fishers Lane, Rockville, MD 20857, and shall be deposited...


Subpart A_General Provisions Sec. 19.1 Scope. 19.5 Reference to Department regulations. 19.6 Code of ethics for government service. 19.10 Food and...


(a) The provisions of 45 CFR part 73, establishing standards of conduct for all Department employees, are fully applicable to all Food and Drug...


The following code of ethics, adopted by Congress on July 11, 1958, shall apply to all Food and Drug Administration employees: Code of Ethics...


of Interest Review Board. (a) The Commissioner shall establish a permanent five-member Conflict of Interest Review Board, which shall review and...


(a) The Office of Internal Affairs, Office of the Commissioner, is responsible for obtaining factual information for the Food and Drug Administration on any...


former employees. Within 1 year after termination of employment with the Food and Drug Administration, no former Food and Drug Administration employee, including...


former employees. No former Food and Drug Administration employee, including a special government employee, shall knowingly act as agent or attorney for anyone other...


Subpart A_Official Testimony and Information Sec. 20.1 Testimony by Food and Drug Administration employees. 20.2 Production of records...


(a) Any request for records of the Food and Drug Administration, whether it be by letter or by a subpena duces tecum or by any other writing, shall...


(a) Upon request, the Food and Drug Administration will certify the authenticity of copies of records that are requested to be disclosed pursuant...


(a) The Food and Drug Administration will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy,...


Drug Administration that is disclosed in an authorized manner to any member of the public is available for disclosure to all members of the public, except that: (a) Data...


both disclosable and nondisclosable information, the nondisclosable information will be deleted and the remaining record will be disclosed unless the two are so...


to the Food and Drug Administration for existing records not prepared for routine distribution to the public shall be deemed to be a request for records pursuant to the...


Act and the provisions of this part apply only to existing records that are reasonably described in a request filed with the Food and Drug Administration pursuant to...


[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR20.25] [Page 220] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 20_PUBLIC INFORMATION--Table of Contents Subpart B_General Policy Sec. 20.25 Retroactive application of regulations. The provisions of this part apply to all records in Food and Drug Administration files. ...


maintained, and revised at least quarterly, for the following Food and Drug Administration records: (1) Final orders published in the Federal Register with respect to...


records submitted to the Food and Drug Administration as confidential, or with any other similar term, raises no obligation by the Food and Drug Administration to regard...


A determination that data or information submitted to the Food and Drug Administration will be held in confidence and will not be available for public disclosure shall...


files. No person may withdraw records submitted to the Food and Drug Administration. All Food and Drug Administration records shall be retained...


(a) The Office responsible for agency compliance with the Freedom of Information Act and this part is: Freedom of Information Staff (HFI-35), Food and Drug...


(a) Unless unusual circumstances dictate otherwise, the Food and Drug Administration shall maintain and dispose of files of requests and reponses...


The names of Food and Drug Administration employees will not be deleted from disclosable records except where such deletion is necessary to prevent disclosure of an...


shall make reasonable efforts to provide a record in any requested form or format if the record is readily reproducible by the agency in that form or format. ...


records, the Food and Drug Administration shall make reasonable efforts to search for records kept in electronic form or format, except when such efforts would...


requests for Food and Drug Administration records shall be made in writing by mailing or delivering the request to the Freedom of Information Staff (HFI-35), Food and...


pursuant to this section shall begin as of the time at which a request for records is logged in by the Freedom of Information Staff pursuant to Sec. 20.40(c). An oral...


Administration may aggregate certain requests by the same requester, or by a group of requesters acting in concert, if the requests involve clearly related matters and the...


component is responsible for determining whether to use a multitrack system to process requests for records maintained by that component. A multitrack system provides...


Administration will provide expedited processing of a request for records when the requester demonstrates a compelling need, or in other cases as determined by the agency....


(a) (1) through (3) of this section state, for each category of request, the type of fees that the Food and Drug Administration will generally charge. However, for...


Assistant Commissioner for Public Affairs (or delegatee) will waive or reduce the fees that would otherwise be charged if disclosure of the information meets both of the...


In situations where the confidentiality of data or information is uncertain and there is a request for public disclosure, the Food and Drug Administration will consult with...


Food and Drug Administration consults with a person who will be affected by a proposed disclosure of data or information contained in Food and Drug Administration records pursuant...


of a request for records, in whole or in part, shall be signed by the Assistant Commissioner for Public Affairs (or delegatee). (b) The name and title or position of each...


The Food and Drug Administration will make every reasonable effort to comply fully with all requests for disclosure of nonexempt records. Nonspecific requests or requests for a...


of a request for a record or document which is contained in Food and Drug Administration files but which is available elsewhere at a lower cost, the person requesting the record...


The Food and Drug Administration is furnishing a number of records to the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield,...


and Drug Administration may furnish requested records to a private contractor for copying after deletion of all nondisclosable data and information. Under these circumstances, the...


disclosure of records shall be permitted an opportunity to review them without the necessity for copying them where the records involved contain only disclosable data...


Whenever the Food and Drug Administration denies a request for a record or portion thereof on the grounds that the record or portion thereof is...


in this subpart shall apply to all Food and Drug Administration records, except as provided in subpart E of this part. Accordingly, a record that is ordinarily...


privileged or confidential. (a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making,...


within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure...


a clearly unwarranted invasion of personal privacy. (a) The names or other information which would identify patients or research subjects in any medical...


(a) Records or information compiled for law enforcement purposes may be withheld from public disclosure pursuant to the provisions of this section to the extent...


(a) The limitations on exemptions established in this subpart shall apply to all Food and Drug Administration records, except as specifically provided herein. Accordingly, a...


(a) Any Food and Drug Administration record that is otherwise exempt from public disclosure pursuant to subpart D of this part is available for public disclosure to...


(a) Except as provided in paragraph (b) of this section, the Commissioner may, in his discretion, disclose part or all of any Food and Drug Administration record that is...


Records of the Food and Drug Administration which the Commissioner has determined are not available for public disclosure, in the form of a regulation published or cross-referenced...


local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees. Data and information otherwise exempt from...


Any Food and Drug Administration record otherwise exempt from public disclosure may be disclosed to other Federal government departments and agencies, except...


Data and information otherwise exempt from public disclosure may be revealed in Food and Drug Administration administrative proceedings pursuant to parts 10, 12, 13, 14, 15,...


the Food and Drug Administration shall be disclosed to Congress upon an authorized request. (b) An authorized request for Food and Drug Administration records by Congress...


(a) A State or local government official commissioned by the Food and Drug Administration pursuant to 21 U.S.C. 372(a) shall have the same status with respect...


Communications with foreign government officials shall have the same status as communications with any member of the public, except that: (a) Investigatory records...


otherwise exempt from public disclosure may be disclosed to contractors with the Food and Drug Administration and their employees for use only in their work for the Food...


action. Nothing in this part or this chapter shall prevent the Food and Drug Administration from using any data or information, whether obtained...


(a) The provisions set forth in this subpart or cross-referenced in paragraph (c) of this section state the way in which specific categories of Food...


(a) All Food and Drug Administration records relating to administrative enforcement action disclosed to any member of the public, including the person who is the subject of...


(a) All records and documents filed in the courts are available for public disclosure unless the court orders otherwise. The Food and Drug Administration will make available for...


and from members of the public, members of Congress, organization or company officials, or other persons, except members of the Executive Branch of the Federal Government...


(a) All written summaries of oral discussions, whether in person or by telephone, with members of the public, members of Congress, organization or company officials, or other...


provided by the Food and Drug Administration. (a) Any list that may be prepared by the Food and Drug Administration of testing and research being conducted by or...


provided by the Food and Drug Administration. (a) The following types of reports and studies prepared by or with funds provided by the Food and Drug Administration...


(a) Food and Drug Administration administrative staff manuals and instructions that affect a member of the public are available for public disclosure. An index of all such...


other departments, agencies, and organizations. (a) All written agreements and understandings signed by the Food and Drug Administration and other...


(a) All data and information obtained by the Food and Drug Administration [[Page 244]] by contract, including all progress reports pursuant to a...


employees. (a) The name, title, grade, position description, salary, work address, and work telephone number for every Food and Drug Administration...


the Food and Drug Administration. (a) The provisions of this section shall apply only to data and information submitted voluntarily to the Food and...


physicians and hospitals. (a) A voluntary drug experience report to the Food and Drug Administration on FDA Form 3500 shall be handled in accordance with the...


Voluntary reports of defects in products subject to the jurisdiction of the Food and Drug Administration are available for public disclosure: (a) If the report is submitted by...


quality assurance agreements. Data and information submitted to the Food and Drug Administration pursuant to a cooperative quality assurance agreement shall...


Data or information in Food and Drug Administration files which provide a means for deciphering or decoding a manufacturing date or sales date or use date contained...


Information submitted to the Food and Drug Administration pursuant to section 510 (a)-(j) of the act shall be subject only to the special disclosure provisions established in...


computer printouts are available for public inspection in the Food and Drug Administration's Freedom of Information Public Room: (1) A numerical listing of all new...


[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR20.118] [Page 246] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 20_PUBLIC INFORMATION--Table of Contents Subpart F_Availability of Specific Categories of Records Sec. 20.118 Advisory committee records. All advisory committee records shall be handled in accordance with the rules established in parts 10, 12, 13, 14, 15, 16, and 19 of this chapter. ...


Names and addresses of individuals in Food and Drug Administration records shall not be sold or rented. Names and addresses shall not be disclosed if disclosure is prohibited as a...


Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room is...


Subpart A_General Provisions Sec. 21.1 Scope. 21.3 Definitions. 21.10 Policy concerning records about individuals. Subpart B_Food and Drug Administration...


(a) Individual means a natural living person who is a citizen of the United States or an alien lawfully admitted for permanent residence. Individual does not include...


Information about individuals in Food and Drug Administration records shall be collected, maintained, used, and disseminated so as to protect the right to privacy of the individual...


Administration Privacy Act Record Systems. (a) The Food and Drug Administration shall issue in the Federal Register on or before August 30 of each year a...


(a) The Food and Drug Administration shall notify the designated Department official, the Office of Management and Budget (Information Systems Division), and the Congress...


(a) Systems of records that are required to be operated, or as a matter of practical necessity must be operated, by contractors to accomplish Food and Drug Administration...


Records Administration. (a) Food and Drug Administration records that are stored, processed, and serviced by the National Archives and Records Administration...


and former Food and Drug Administration employees desiring access to personnel records about themselves should consult system notices applicable to the agency's personnel...


individual is entitled to have access to any medical records about himself in Privacy Act Record Systems maintained by the Food and Drug Administration. (b) The Food...


21.40 Procedures for submitting requests for notification and access. (a) An individual may request that the Food and Drug Administration notify...


21.41 Processing of requests. (a) An individual or his guardian under Sec. 21.75 shall not be required to show any justification or need to obtain...


21.42 Responses to requests. (a) The FDA shall respond to an individual's request for notification as to whether a Privacy Act Record System contains...


21.43 Access to requested records. (a) Access may be granted to requested records by: (1) Mailing a copy of the records to the requesting individual, or ...


21.44 Verification of identity. (a) An individual seeking access to records in a Privacy Act Record System may be required to comply with reasonable requirements...


21.45 Fees. (a) Where applicable, fees for copying records shall be charged in accordance with the schedule set forth in this section. Fees may only be...


amendment of records. (a) An individual who received access to a record about himself under subpart D of this part may request that the record be amended if...


(a) The Food and Drug Administration shall take one of the following actions on a request for amendment of records as promptly as possible: (1) Amend any portion...


amend records. (a) If an individual disagrees with a refusal under Sec. 21.51(a)(2) to amend a record, he or she may appeal that refusal to the Commissioner of Food...


When an individual has filed a statement of disagreement under Sec. 21.52(b)(2), the Food and Drug Administration shall: (a) Mark any portion of the record that...


agencies. Whenever the Food and Drug Administration is notified that a record that it received from another agency was amended or is the subject of a statement...


Administration that record systems should be exempted from the Privacy Act only to the extent essential to the performance of law enforcement functions under the laws that...


for law enforcement purposes, including criminal law enforcement purposes, in the Food and Drug Administration Privacy Act Record Systems listed in paragraph (b) of...


a Privacy Act Record System is exempt and the requested records are unavailable under Sec. 21.61, an individual may nevertheless make a request under Sec. 21.40 for...


21.70 Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required. (a) A record about an individual which is...


21.71 Disclosure of records in Privacy Act Record Systems; accounting required. (a) Except as provided in Sec. 21.70, a record about an individual...


21.72 Individual consent to disclosure of records to other persons. (a) Individuals may consent to disclosure of records about themselves to other persons...


21.73 Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems. (a) The Food and Drug Administration shall...


21.74 Providing notice that a record is disputed. Whenever an individual has filed a statement of disagreement with the Food and Drug Administration...


21.75 Rights of legal guardians. For the purposes of this part, the parent of any individual who is a minor or the legal guardian of any individual who has...


Subpart A_General Provisions Sec. 25.1 Purpose. 25.5 Terminology. 25.10 Policies and NEPA planning. Subpart B_Agency Actions...


apply to the terms used in this part are set forth in the CEQ regulations under 40 CFR part 1508. The terms and the sections of 40 CFR part 1508 in which they are...


(a) All FDA's policies and programs will be planned, developed, and implemented to achieve the policies declared by NEPA and required by CEQ's regulations to ensure responsible...


(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion...


There are certain regulatory actions that, because of their immediate importance to the public health or safety, may make full adherence to the...


an environmental assessment. Any proposed action of a type specified in this section ordinarily requires at least the preparation of an EA, unless it is an action in...


As required under 40 CFR 1508.4, FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate...


an environmental impact statement. (a) There are no categories of agency actions that routinely significantly affect the quality of the human environment and...


actions listed in this section and Sec. Sec. 25.31 through 25.34 are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS: ...


The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS: (a) Action on an...


The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS: ...


actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS: (a) Action on an NADA,...


The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS: (a) Action on...


(a) As defined by CEQ in 40 CFR 1508.9, an EA is a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether...


(a) As defined by the CEQ regulations (40 CFR 1508.13), a FONSI is a document prepared by a Federal agency stating briefly why an action, not otherwise excluded,...


(a) As defined by CEQ regulations (40 CFR 1508.11) and section 102(2)(C) of NEPA, an EIS should be a clear, concise, and detailed written statement describing: ...


(a) In cases requiring environmental impact statements, at the time of its decision, the agency shall prepare a concise public record of decision. (b) The record of...


For actions requiring the preparation of an EIS, FDA and other affected Federal agencies will agree which will be the lead agency and which will be the cooperating...


(a) The person designated in part 5 of this chapter as the responsible agency official for the underlying action is responsible for preparing environmental documents or...


25.50 General information. (a) To the extent actions are not protected from disclosure by existing law applicable to the agency's operation, FDA...


25.51 Environmental assessments and findings of no significant impact. (a) Data and information that are protected from disclosure by 18 U.S.C. 1905 or...


25.52 Environmental impact statements. (a) If FDA determines that an EIS is necessary for an action involving investigations or approvals for drugs,...


(a) In accordance with Executive Order 12114, ``Environmental Effects Abroad of Major Federal Actions'' of January 4, 1979 (44 FR 1957, January 9, 1979),...


DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents Sec. 26.0 General. ...


Sec. 26.1 Definitions. (a) Enforcement means action taken by an authority to protect the public from products of suspect quality, safety,...


Sec. 26.2 Purpose. The provisions of this subpart govern the exchange between the parties and normal endorsement by the receiving...


Manufacturing Practices Sec. 26.3 Scope. (a) The provisions of this subpart shall apply to pharmaceutical inspections carried out in the United States and Member...


Sec. 26.4 Product coverage. (a) The provisions of this subpart will apply to medicinal products for human or animal use, intermediates and...


Sec. 26.5 Length of transition period. A 3-year transition period will start immediately after the effective date described in...


Sec. 26.6 Equivalence assessment. (a) The criteria to be used by the parties to assess equivalence are listed in Appendix D of this...


Sec. 26.7 Participation in the equivalence assessment and determination. The authorities listed in Appendix B of this subpart will...


Sec. 26.8 Other transition activities. As soon as possible, the authorities will jointly determine the essential information which must be...


Manufacturing Practices Sec. 26.9 Equivalence determination. (a) Equivalence is established by having in place regulatory systems covering the criteria referred to...


Sec. 26.10 Regulatory authorities not listed as currently equivalent. Authorities not currently listed as equivalent, or not equivalent for...


Sec. 26.11 Start of operational period. (a) The operational period shall start at the end of the transition period and its provisions apply...


Sec. 26.12 Nature of recognition of inspection reports. (a) Inspection reports (containing information as established under Sec. 26.8), including...


Sec. 26.13 Transmission of postapproval inspection reports. Postapproval good manufacturing practice (GMP) inspection reports concerning...


Manufacturing Practices Sec. 26.14 Transmission of preapproval inspection reports. (a) A preliminary notification that an inspection may have to take place will...


Sec. 26.15 Monitoring continued equivalence. Monitoring activities for the purpose of maintaining equivalence shall include review of the...


Sec. 26.16 Suspension. (a) Each party has the right to contest the equivalence of a regulatory authority. This right will be exercised in...


Sec. 26.17 Role and composition of the Joint Sectoral Committee. (a) A Joint Sectoral Committee is set up to monitor the activities under both...


Manufacturing Practices Sec. 26.18 Regulatory collaboration. (a) The parties and authorities shall inform and consult one another, as permitted by law, on proposals...


Sec. 26.19 Information relating to quality aspects. The authorities will establish an appropriate means of exchanging information on any...


Sec. 26.20 Alert system. (a) The details of an alert system will be developed during the transitional period. The system will be maintained...


Manufacturing Practices Sec. 26.21 Safeguard clause. Each party recognizes that the importing country has a right to fulfill its legal responsibilities by...


(a) The purpose of this subpart is to specify the conditions under which a party will accept the results of quality system-related evaluations and inspections...


(a) The provisions of this subpart shall apply to the exchange and, where appropriate, endorsement of the following types of reports from conformity assessment bodies...


(a) There are three components to this subpart each covering a discrete range of products: (1) Quality System Evaluations. U.S.-type surveillance/postmarket...


The regulatory authorities shall have the responsibility of implementing the provisions of this subpart, including the designation and monitoring of...


of transition period. There will be a 3-year transition period immediately following the date described in Sec. 26.80(a). During the transition period, the parties...


CAB's. Each party shall designate conformity assessment bodies (CAB's) to participate in confidence building activities by transmitting to the other party a list of...


activities. (a) At the beginning of the transitional period, the Joint Sectoral Group will establish a joint confidence building program calculated to...


activities. (a) During the transition period, the parties will jointly determine the necessary information which must be present in quality system and...


(a) In the final 6 months of the transition period, the parties shall proceed to a joint assessment of the equivalence of the conformity assessment bodies...


operational period. (a) The operational period will start at the end of the transition period after the parties have developed the list of conformity assessment...


of quality system evaluation reports. (a) Listed European Community (EC) conformity assessment bodies (CAB's) will provide FDA with reports of quality...


of product evaluation reports. (a) European Community (EC) conformity assessment bodies (CAB's) listed for this purpose will, subject to the specifications...


quality system evaluation reports. Quality system evaluation reports covered by Sec. 26.41 concerning products covered by this subpart shall be transmitted to the...


product evaluation reports. Transmission of product evaluation reports will take place according to the importing party's...


[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR26.45] [Page 286] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 26_MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE Subpart B_Specific Sector Provisions for Medical Devices Sec. 26.45 Monitoring continued equivalence. Monitoring activities will be carried out in accordance with Sec. 26.69. ...


CAB's. (a) During the operational period, additional conformity assessment bodies (CAB's) will be considered for equivalence using the procedures and...


the Joint Sectoral Committee. (a) The Joint Sectoral Committee for this subpart is set up to monitor the activities under both the transitional and...


During both the transitional and operational phases of this subpart, both parties intend to continue to participate in the activities of the Global Harmonization Task...


(a) The parties and authorities shall inform and consult with one another, as permitted by law, of proposals to introduce new controls or to change...


(a) The parties and authorities shall inform and consult with one another, as permitted by law, of proposals to introduce new controls or to change...
...


(a) The following terms and definitions shall apply to this subpart only: (1) Designating Authority means a body with power to designate, monitor, suspend,...


This part specifies the conditions by which each party will accept or recognize results of conformity assessment procedures, produced by the other party's conformity...


(a) The United States shall, as specified in subparts A and B of this part, accept or recognize results of specified procedures, used in assessing conformity to...


(a) This part applies to conformity assessment procedures for products and/or processes and to other related cooperative activities as described in this part. ...


The parties agree to implement the transitional commitments on confidence building as specified in subparts A and B of this part. (a) The parties agree that...


The parties shall ensure that the designating authorities specified in subpart B of this part have the power and competence in their respective territories to carry...


The following procedures shall apply with regard to the designation of conformity assessment bodies (CAB's) and the inclusion of such bodies in the list...


bodies. The following procedures shall apply with regard to the suspension of a conformity assessment body (CAB) listed in subpart B of this part. (a)...


assessment bodies. The following procedures shall apply with regard to the withdrawal from subpart B of this part of a conformity assessment body (CAB): (a)...


bodies. The following shall apply with regard to the monitoring of conformity assessment bodies (CAB's) listed in subpart B of this part: (a)...


Each party recognizes that the conformity assessment bodies (CAB's) listed in subpart B of this part fulfill the conditions of eligibility to assess conformity...


(a) The parties shall exchange information concerning the implementation of the legislative, regulatory, and administrative provisions identified in subparts A and B of...


[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR26.72] [Page 304] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 26_MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE Subpart C_``Framework'' Provisions Sec. 26.72 Sectoral contact points. Each party shall appoint and confirm in writing contact points to be responsible for activities under subparts A and B of this part. ...


(a) A Joint Committee consisting of representatives of the United States and the European Community (EC) will be established. The Joint Committee shall be responsible for...


(a) Nothing in this part shall be construed to limit the authority of a party to determine, through its legislative, regulatory, and administrative...


Either party may suspend its obligations under subpart A or B of this part, in whole or in part, if: (a) A party suffers a loss of market access for...


(a) Each party agrees to maintain, to the extent required under its laws, the [[Page 306]] confidentiality of information exchanged under this part. (b)...


shall endeavor to ensure that fees imposed for services under this part shall be commensurate with the services provided. Each party shall ensure that, for the sectors...


Except where there is written agreement between the parties, obligations contained in mutual recognition agreements concluded by either party with a party not...


The agreement from which this part is derived shall apply, on the one hand, to the territories in which the Treaty establishing the European Community (EC) is applied,...


termination. (a) The ``Agreement on Mutual Recognition Between the United States of America and the European Community,'' from which this part is derived,...


(a) The sectoral annexes referred to in Sec. 26.80(a), as well as any new sectoral annexes added pursuant to Sec. 26.80(b), shall form an integral part of the ``Agreement on...


Subpart A_General Provisions Sec. 50.1 Scope. 50.3 Definitions. Subpart B_Informed Consent of Human Subjects 50.20 General requirements...


(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201--902, 52 Stat. 1040 et seq. as amended (21 U.S.C. 321--392)). (b) Application for research...


Source: 46 FR 8951, Jan. 27, 1981, unless otherwise noted. Except as provided in Sec. Sec. 50.23 and 50.24, no investigator may involve a human being as...


(a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both...


emergency research. (a) The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section...


(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject: (1) A statement that the study...


(a) Except as provided in Sec. 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject...


66 FR 20598, Apr. 24, 2001, unless otherwise noted. In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter, each IRB...


greater than minimal risk. Any clinical investigation within the scope described in Sec. Sec. 50.1 and 56.101 of this chapter in which no greater than minimal risk...


than minimal risk but presenting the prospect of direct benefit to individual subjects. Any clinical investigation within the scope described in Sec. Sec....


greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder...


approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. If an IRB does...


parents or guardians and for assent by children. (a) In addition to the determinations required under other applicable sections of this subpart D, the IRB...


are wards of the State or any other agency, institution, or entity can be included in clinical investigations approved under Sec. 50.53 or Sec. 50.54 only if such...


and disclosure requirements. 54.5 Agency evaluation of financial interests. 54.6 Recordkeeping and record retention. Authority: 21 U.S.C. 321, 331,...


the outcome of clinical studies means compensation that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater...


for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification...


submit a list of all clinical investigators who conducted covered clinical studies to determine whether the applicant's product meets FDA's marketing...


will evaluate the information disclosed under Sec. 54.4(a)(2) about each covered clinical study in an application to determine the impact of any disclosed...


be retained. An applicant who has submitted a marketing application containing covered clinical studies shall keep on file certain information pertaining to the...


Subpart A_General Provisions Sec. 56.101 Scope. 56.102 Definitions. 56.103 Circumstances in which IRB review is required. 56.104 Exemptions from...


(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)). (b) Application for research...


(a) Except as provided in Sec. Sec. 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812,...


The following categories of clinical investigations are exempt from the requirements of this part for IRB review: (a) Any investigation which commenced before July 27, 1981 and...


of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements contained in these regulations, including the requirements for...


shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall...


In order to fulfill the requirements of these regulations, each IRB shall: (a) Follow written procedures: (1) For conducting its initial and continuing review of...


An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations. (b) An...


research involving no more than minimal risk, and for minor changes in approved research. (a) The Food and Drug Administration has established, and...


(a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects...


by these regulations that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However,...


research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has...


these regulations, institutions involved in multi- institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed...


where appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals...


(a) If apparent noncompliance with these regulations in the operation of an IRB is observed by an FDA investigator during an inspection, the inspector will present an oral...


(a) Whenever the IRB or the institution has failed to take adequate steps to correct the noncompliance stated in the letter sent by the agency under...


A determination that the Food and Drug Administration has disqualified an institution and the administrative record regarding that determination...


An IRB or an institution may be reinstated if the Commissioner determines, upon an evaluation of a written submission from the IRB or institution that explains...


Disqualification of an IRB or of an institution is independent of, and neither in lieu of nor a precondition to, other proceedings or actions authorized...


Subpart A_General Provisions Sec. 58.1 Scope. 58.3 Definitions. 58.10 Applicability to studies performed under grants...


As used in this part, the following terms shall have the meanings specified: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902,...


studies performed under grants and contracts. When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the Food and...


a testing facility. (a) A testing facility shall permit an authorized employee of the Food and Drug Administration, at reasonable times and in a reasonable manner,...


(a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and...


management. For each nonclinical laboratory study, testing facility management shall: (a) Designate a study director as described in Sec. 58.33, before...


For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall...


unit. (a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the...


Each testing facility shall be of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. It shall be designed so that there is...


(a) A testing facility shall have a sufficient number of animal rooms or areas, as needed, to assure proper: (1) Separation of species or test systems, (2)...


There shall be storage areas, as needed, for feed, bedding, supplies, and equipment. Storage areas for feed and bedding shall be separated from areas housing...


test and control articles. (a) As necessary to prevent contamination or mixups, there shall be separate areas for: (1) Receipt and storage of the test and...


Separate laboratory space shall be provided, as needed, for the performance of the routine and specialized procedures required by nonclinical...


facilities. Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens...


Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and...


of equipment. (a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall...


procedures. (a) A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that...


solutions. All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration...


(a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals. (b) All newly received animals from outside...


control article characterization. (a) The identity, strength, purity, and composition or other characteristics which will appropriately define the test or...


control article handling. Procedures shall be established for a system for the handling of the test and control articles to ensure that: (a) There is...


articles with carriers. (a) For each test or control article that is mixed with a carrier, tests by appropriate analytical methods shall be conducted: (1)...


Protocol. (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study....


Conduct of a nonclinical laboratory study. (a) The nonclinical laboratory study shall be conducted in accordance with the protocol. (b) The test systems shall...


nonclinical laboratory study results. (a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to,...


retrieval of records and data. (a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and...


records. (a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in...


Purpose. (a) The purposes of disqualification are: (1) To permit the exclusion from consideration of completed studies that were conducted by a testing...


Grounds for disqualification. The Commissioner may disqualify a testing facility upon finding all of the following: (a) The testing facility failed to comply with one...


Notice of and opportunity for hearing on proposed disqualification. (a) Whenever the Commissioner has information indicating that grounds exist under Sec. 58.202 which in...


Final order on disqualification. (a) If the Commissioner, after the regulatory hearing, or after the time for requesting a hearing expires without a request being made,...


Actions upon disqualification. (a) Once a testing facility has been disqualified, each application for a research or marketing permit, whether approved or not, containing...


Public disclosure of information regarding disqualification. (a) Upon issuance of a final order disqualifying a testing facility under Sec. 58.206(a), the Commissioner may...


Alternative or additional actions to disqualification. (a) Disqualification of a testing facility under this subpart is independent of, and neither in lieu of nor a...


Suspension or termination of a testing facility by a sponsor. Termination of a testing facility by a sponsor is independent of, and neither in lieu of nor a precondition...


Reinstatement of a disqualified testing facility. A testing facility that has been disqualified may be reinstated as an acceptable source of nonclinical laboratory studies...


Provisions Sec. 60.1 Scope. 60.2 Purpose. 60.3 Definitions. Subpart B_Eligibility Assistance 60.10 FDA assistance...


to establish a thorough yet efficient process for the Food and Drug Administration review of patent term restoration applications. To achieve this purpose, the regulations...


35 U.S.C. 156 apply to those terms when used in this part. (b) The following definitions of terms apply to this part: (1) The term Act means the Federal Food, Drug,...


written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible...


(a) FDA will consult its records and experts to verify the dates contained in the application and to determine the length of the product's...


In determining a product's regulatory review period, which consists of the sum of the lengths of a testing phase and an approval phase, FDA will review the information...


(a) Any person may request a revision of the regulatory review period determination within 60 days after its initial publication in the Federal Register....


(a) FDA will consider a regulatory review period determination to be final upon expiration of the 180-day period for filing a due diligence petition under...


(a) FDA will determine the regulatory review period for a product within 30 days of the receipt of a written request from PTO for such a determination and a...


(a) Any person may file a petition with FDA, no later than 180 days after the publication of a regulatory review period determination under Sec. 60.20, that challenges...


applicant shall file with FDA a written response to the petition no later than 30 days after the applicant's receipt of a copy of the petition. (b) The applicant's response...


days after FDA receives a petition filed under Sec. 60.30(a), the agency will either deny the petition under paragraph (b) or (c) of this section or investigate and determine under...


due diligence of an applicant, FDA will examine the facts and circumstances of the applicant's actions during the regulatory review period to determine whether the...


may request, not later than 60 days after the publication under Sec. 60.34(a) of FDA's due diligence determination, that FDA conduct an informal hearing on the due...


FDA will notify the requesting party, the applicant, and the petitioner, orally or in writing, of the date, time, and location of the hearing. The agency will provide...


shall be conducted in accordance with this part, supplemented by the nonconflicting procedures in part 16. During the due diligence hearing, the applicant and the petitioner...


the completion of the due diligence hearing, the Commissioner will affirm or revise the determination made under Sec. 60.34(a) and will publish the due diligence redetermination...


Subpart A_General Provisions Sec. 70.3 Definitions. 70.5 General restrictions on use of color additives. 70.10 Color additives in standardized foods and new...


(a) Color additives for use in the area of the eye. No listing or certification of a color additive shall be considered to authorize the use of any such color additive in any...


(a) Standardized foods. (1) Where a petition is received for issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401...


cause similar or related pharmacological or biological effects, and, in the absence of evidence to the contrary, those that do so will be considered to have additive...


of a color additive shall be accompanied by a deposit of $3,000.00 if the proposal is for listing the color additive for use generally in or on foods, in or on drugs, and...


Straight colors shall be packaged in containers which prevent changes in composition. Packages shall be sealed so that they cannot be opened without...


dyes). (a) General labeling requirements. All color additives shall be labeled with sufficient information to assure their safe use and to allow a determination...


section 721(b)(5)(A)(iii) of the act, the following safety factor will be applied in determining whether the proposed use of a color additive will be safe: Except where...


(a) In deciding whether a petition is complete and suitable for filing and in reaching a decision on any petition filed, the Commissioner will apply the ``safe-for-use''...


of a petition or a proposal to list a color additive or to alter an existing listing, the data before the Commissioner fail to show that it would be safe to list the...


(a) Color additives that may be ingested. Whenever (1) the scientific data before the Commissioner (either the reports from the scientific literature or the results...


All requests for and procedures governing any advisory committee on the anticancer clause shall be subject to the provisions of part 14 of this chapter,...


consider requests by any interested person who desires the Food and Drug Administration to conduct scientific studies to support a petition for a regulation for a color additive....


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...


the petition involves a new drug, the Commissioner, within 15 days after receipt, will notify the petitioner of acceptance or nonacceptance of a petition, and if not accepted...


request samples 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...


withdrawal of petitions without prejudice. (a) Extension of time for studying petitions. If the Commissioner determines that additional time is needed to...


petitions. (a) The following data and information in a color additive petition are available for public disclosure, unless extraordinary circumstances...


A manufacturer, packer, or distributor of a color additive or color additive mixture may petition for an exemption from certification pursuant to part 10 of this chapter. Any...


The Commissioner will forward for publication in the Federal Register, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in...


deceptive use of a color additive for which a regulation has issued. The Commissioner shall refuse to issue a regulation listing a color additive, if in...


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...


If information becomes available to the Commissioner that a color additive that has been granted exemption from certification should not, for the protection of the...


Commissioner's initiative. Where a petition for a regulation to list a color additive has not been received and the Commissioner has available facts which...


(a) Objections and hearings relating to color additive regulations under section 721 (b) and (c) of the act shall be governed by parts 10, 12, 13, 14, 15, 16, and 19...


(a) A shipment or other delivery of a color additive or of a food, drug, or cosmetic containing such a color additive for investigational use by experts qualified...


for food use exempt from certification. Subpart A_Foods Sec. 73.1 Diluents in color additive mixtures for food...


(a) Identity. (1) The color additive annatto extract is an extract prepared from annatto seed, Bixa orellana L., [[Page 369]] using any one or an appropriate...


(a) Identity. (1) The color additive astaxanthin is 3, 3'- dihydroxy-[beta], [beta]-carotene-4, 4'-dione. (2) Astaxanthin may be added to the fish feed only as a component of...


(a) Identity. (1) The color additive dehydrated beets is a dark red powder prepared by dehydrating sound, mature, good quality, edible beets. (2) Color...


(a) Identity. The color additive ultramarine blue is a blue pigment obtained by calcining a mixture of kaolin, sulfur, sodium carbonate, and carbon at temperatures above 700...


(a) Identity. (1) The color additive canthaxanthin is [beta]- carotene-4,4'-dione. [[Page 371]] (2) Color additive mixtures for food use made with canthaxanthin...


(1) The color additive caramel is the dark-brown liquid or solid material resulting from the carefully controlled heat treatment of the following...


(a) Identity. (1) The color additive is [beta]-apo-8'-carotenal. (2) Color additive mixtures for food use made with [beta]-apo-8'- carotenal may contain only diluents that...


(a) Identity. (1) The color additive is [beta]-carotene prepared synthetically or obtained from natural sources. [[Page 373]] (2) Color additive mixtures for food...


(a) Identity. (1) The color additive cochineal extract is the concentrated solution obtained after removing the alcohol from an aqueous-alcoholic extract of...


(a) Identity. (1) The color additive sodium copper chlorophyllin is a green to black powder prepared from chlorophyll by saponification and replacement of magnesium...


cottonseed flour. (a) Identity. (1) The color additive toasted partially defatted cooked cottonseed flour is a product prepared as follows: Food quality...


(a) Identity. The color additive ferrous gluconate is the ferrous gluconate defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 122- 123, which is incorporated by reference....


(a) Identity. The color additive ferrous lactate is the ferrous lactate defined in Sec. 184.1311 of this chapter. (b) Specifications. Ferrous lactate shall meet the...


(a) Identity. (1) The color additive grape color extract is an aqueous solution of anthocyanin grape pigments made from Concord grapes or a dehydrated water soluble...


(a) Identity. (1) The color additive grape skin extract (enocianina) is a purplish-red liquid prepared by the aqueous extraction (steeping) of the fresh deseeded...


(a) Identity. (1) The color additive haematococcus algae meal consists of the comminuted and dried cells of the alga Haematococcus pluvialis. (2) Haematococcus...


(a) Identity. (1) The color additive synthetic iron oxide consists of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is...


(1) The color additive fruit juice is prepared either by expressing the juice from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit....


(a) Identity. (1) The color additive vegetable juice is prepared either by expressing the juice from mature varieties of fresh, edible vegetables, or by the water infusion of the...


(a) Identity. The color additive dried algae meal is a dried mixture of algae cells (genus Spongiococcum, separated from its culture broth), molasses, cornsteep liquor, and...


and extract. (a) Identity. (1) The color additive tagetes (Aztec marigold) meal is the dried, ground flower petals of the Aztec marigold (Tagetes erecta L.) mixed...


(1) The color additive carrot oil is the liquid or the solid portion of the mixture or the mixture itself obtained by the hexane extraction of edible carrots (Daucus carota...


(a) Identity. (1) The color additive corn endosperm oil is a reddish-brown liquid composed chiefly of glycerides, fatty acids, sitosterols, and carotenoid pigments obtained...


(1) The color additive paprika is the ground dried pod of mild capsicum (Capsicum annuum L.). The definition of paprika in this paragraph is for the purpose of identity as...


(a) Identity. (1) The color additive paprika oleoresin is the combination of flavor and color principles obtained from paprika (Capsicum annuum L.) by extraction, using any one or...


(a) Identity. (1) The color additive phaffia yeast consists of the killed, dried cells of a nonpathogenic and nontoxicogenic strain of the yeast Phaffia rhodozyma. (2)...


(1) The color additive riboflavin is the riboflavin defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 262-263, which is incorporated by reference. Copies may be...


(1) The color additive saffron is the dried stigma of Crocus sativus L. The definition of saffron in this paragraph is for the purpose of identity as a color additive only,...


(a) Identity. (1) The color additive titanium dioxide is synthetically prepared TiO2, free from admixture with other substances. (2) Color additive mixtures for...


(1) The color additive turmeric is the ground rhizome of Curcuma longa L. The definition of turmeric in this paragraph is for the purpose of identity as a color additive only,...


(a) Identity. (1) The color additive turmeric oleoresin is the combination of flavor and color principles obtained from turmeric (Curcuma longa L.) by extraction using any one...


for drug use exempt from certification. The following diluents may be safely used in color additive mixtures that are exempt from certification and...


(a) Identity. (1) The color additive alumina (dried aluminum hydroxide) is a white, odorless, tasteless, amorphous powder consisting essentially of...


(a) Identity. The color additive chromium-cobalt-aluminum oxide is a blue-green pigment obtained by calcining a mixture of chromium oxide, cobalt carbonate,...


(a) Identity. The color additive ferric ammonium citrate consists of complex chelates prepared by the interaction of ferric hydroxide with citric acid in the presence...


(a) Identity and specifications. (1) The color additive annatto extract shall conform in identity and specifications to the requirements of Sec. 73.30(a)(1) and (b). (2)...


(a) Identity. (1) The color additive calcium carbonate is a fine, white, synthetically prepared powder consisting essentially of precipitated calcium...


(a) Identity and specifications. (1) The color additive canthaxanthin shall conform in identity and specifications to the requirements of Sec. 73.75(a)(1) and (b). (2)...


and specifications. (1) The color additive caramel shall conform in identity and specifications to the requirements of Sec. 73.85(a) (1), (2), and (3) and (b). (2)...


(a) Identity and specifications. (1) The color additive [beta]- carotene shall conform in identity and specifications to the requirements of Sec. 73.95(a)(1) and (b). (2)...


(a) Identity and specifications. (1) The color additives cochineal extract and carmine shall conform in identity and specifications to the requirements of Sec....


complex). (a) Identity. (1) The color additive potassium sodium copper chlorophyllin is a green to black powder obtained from chlorophyll...


(a) Identity. (1) The color additive dihydroxyacetone is 1,3- dihydroxy-2-propanone. (2) Color additive mixtures for drug use made with dihydroxyacetone may contain...


(a) Identity. (1) The color additive bismuth oxychloride is a synthetically prepared white or nearly white amorphous or finely crystalline, odorless powder consisting...


(a) Identity. (1) The color additive synthetic iron oxide consists of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It...


(a) Identity. (1) The color additive ferric ammonium ferrocyanide is the blue pigment obtained by oxidizing under acidic conditions with sodium dichromate the...


(a) Identity. (1) The color additive ferric ferrocyanide is a ferric hexacyanoferrate pigment characterized by the structual...


(a) Identity. (1) The color additive chromium hydroxide green is principally hydrated chromic sesquioxide (Cr2O3[middot]XH2O). ...


(a) Identity. (1) The color additive chromium oxide greens is principally chromic sesquioxide (Cr2O3). (2) Color additive mixtures for drug use made...


(1) The color additive guanine is the crystalline material obtained from fish scales and consists principally of the two purines, guanine and hypoxanthine. The guanine...


Identity. The color additive pyrogallol is 1,2,3- trihydroxybenzene. (b) Specifications. Pyrogallol shall conform to the following specifications and shall be free...


(a) Identity. (1) The color additive pyrophyllite is a naturally occurring mineral substance consisting predominantly of a hydrous aluminum...


(a) Identity. The color additive logwood extract is a reddish brown- to-black solid material extracted from the heartwood of the leguminous tree Haematoxylon campechianum. The...


(1) The color additive mica is a white powder obtained from the naturally occurring mineral, muscovite mica, consisting predominantly of a potassium aluminum...


The color additive talc is a finely powdered, native, hydrous magnesium silicate sometimes containing a small proportion of aluminum silicate. (2) Color...


(a) Identity and specifications. (1) The color additive titanium dioxide shall conform in identity and specifications to the requirements of Sec. 73.575(a)(1) and (b). ...


(a) Identity. (1) The color additive aluminum powder shall be composed of finely divided particles of aluminum prepared from virgin aluminum. It is free from admixture with...


(a) Identity. (1) The color additive bronze powder is a very fine metallic powder prepared from alloys consisting principally of virgin electrolytic copper and zinc with small amounts...


(a) Identity. (1) The color additive copper powder is a very fine free-flowing metallic powder prepared from virgin electrolytic copper. It contains small amounts of stearic or...


Identity. (1) The color additive zinc oxide is a white or yellow-white amorphous powder manufactured by the French process (described as the indirect process whereby zinc metal...


(a) Identity and specification. The color additive annatto shall conform in identify and specification to the requirements for annatto extract in Sec. 73.30(a) (1) and (b). ...


and specifications. The color additive caramel shall conform in identity and specifications to the requirements of Sec. 73.85(a)(1), (2), and (3) and (b). (b) Uses...


and specifications. The color additive carmine shall conform in identity and specifications to the requirements of Sec. 73.100 (a)(2) and (b)(2). (b) Use...


(a) Identity and specifications. The color additive [beta]-carotene shall conform in identity and specifications to the requirements of Sec. 73.95(a)(1) and (b). (b) Uses...


(a) Identity. The color additive bismuth citrate is the synthetically prepared crystalline salt of bismuth and citric acid, consisting principally...


(a) Identity. The color additive disodium EDTA-copper is disodium [[N,N'- 1,2- ethanediylbis[N - (carboxymethyl) glycinato]] (4-)- N,N',O,O',O\N\,O\N\'] cuprate (2-). ...


(chlorophyllin-copper complex). (a) Identity and specifications. The color additive potassium sodium copper chlorophyllin shall conform in identity...


(a) Identity and specifications. The color additive dihydroxyacetone shall conform in identity and specifications to the requirements of Sec. 73.1150 (a)(1) and (b). ...


(a) Identity and specifications. (1) The color additive bismuth oxychloride shall conform in identity and specifications to the requirements of Sec. 73.1162(a)(1) and (b). ...


(a) Identity. (1) The color additive, guaiazulene, is principally 1,4-dimethyl-7-isopropyl-azulene. (2) Color additive mixtures of guaiazulene for cosmetic use may contain...


(a) Identity. The color additive henna is the dried leaf and petiole of Lawsonia alba Lam. (Lawsonia inermis L.). It may be identified by its characteristic odor and by...


(a) Identity. The color additives iron oxides consist of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture...


(a) Identity and specifications.The color additive ferric ammonium ferrocyanide shall conform in identify and specifications to the requirements of Sec. 73.1298...


(a) Identity and specifications. The color additive ferric ferrocyanide shall conform in identity and specifications to the requirements of Sec. 73.1299(a)(1) and (b). ...


(a) Identity and specifications.The color additive chromium hydroxide green shall conform in identity and specifications to the requirements of Sec. 73.1326 (a)(1)...


(a) Identity and specifications. The color additive chromium oxide greens shall conform in identify and specifications to the requirements of Sec. 73.1327 (a)(1) and (b). ...


and specifications. (1) The color additive guanine shall conform in identity and specifications to the requirements of Sec. 73.1329 (a)(1) and (b). (2) Color...


(a) Identity. The color additive lead acetate is the trihydrate of lead (2+) salt of acetic acid. The color additive has the chemical formula...


(a) Identity and specifications. The color additive pyrophyllite shall conform in identity and specifications to the requirements of Sec. 73.1400 (a)(1) and (b). (b) Uses...


and specifications. The color additive mica shall conform in identity and specifications to the requirements of Sec. 73.1496(a)(1) and (b). (b) Uses and restrictions....


(a) Identity. (1) The color additive, silver, is a crystalline powder of high purity silver prepared by the reaction of silver nitrate with ferrous sulfate in the presence of...


(a) Identity and specifications. The color additive titanium dioxide shall conform in identity and specifications to the requirements on Sec. 73.575 (a)(1) and (b). (b)...


(a) Identity and specifications. The color additive aluminum powder shall conform in identity and specifications to the requirements of Sec. 73.1645 (a)(1) and (b). (b)...


(a) Identity and specifications. The color additive bronze powder shall conform in identity and specifications to the requirements of Sec. 73.1646 (a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive copper powder shall conform in identity and specifications to the requirements of Sec. 73.1647 (a)(1) and (b). (b)...


(a) Identity. The color additives, ultramarines (blue, green, pink, red, and violet) are pigments obtained by calcining at temperatures above 700 [deg]C. a mixture of kaolin,...


(a) Identity. The color additive manganese violet is a violet pigment obtained by reacting phosphoric acid, ammonium dihydrogen orthophosphate, and manganese dioxide at...


(a) Identity and specifications. The color additive zinc oxide shall conform in identity and specifications to the requirements of Sec. 73.1991 (a)(1) and (b). (b) Uses...


(a) Identity. The color additive luminescent zinc sulfide is zinc sulfide containing a copper activator. Following excitation by daylight or a suitable artificial...


copolymers. (a) Identity. The color additives are...


cene dione. (a) Identity. The color additive is 1,4-bis[(2-methyl phenyl) amino]-9,10-anthra cene dione (CAS Reg. No. 6737-68-4). (b) Uses...


phenyl amino]anthra quinone copolymers. (a) Identity. The color additive is 1,4-bis[4-(2-metha cryloxy ethyl) phenyl amino] anthra quinone (CAS Reg....


(a) Identity. The color additive is carbazole violet (Pigment Violet 23) (CAS Reg. No. 6358-30-1, Colour Index No. 51319). (b) Uses and restrictions. (1) The...


oil soluble. (a) Identity. The color additve is chlorophyllin-copper complex, oil soluble. The chlorophyllin is obtained by extraction from a mixture of fescue...


(a) Identity. The color additive chromium-cobalt-aluminum oxide (Pigment Blue 36) (CAS Reg. No. 68187-11-1, Colour Index No. 77343) shall conform in identity...


(a) Identity and specifications. The color additive chromium oxide greens (chromic oxide) (CAS Reg. No. 1308-38-9), Color Index No. 77288, shall conform in identity...


(a) Identity. The color additive is C.I. Vat Orange 1, Colour Index No. 59105. (b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section...


(a) Identity. The color additive2-[[2,5-diethoxy-4-[(4-methyl phenyl) thio] phenyl] azo]-1,3,5-benzene triol is formed...


[2',3':6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone. (a) Identity. The color additive is 16,23-dihydrodinaphtho [2,3- a:2',3'-i]...


(a) Identity. The color additive is N,N'-(9,10-dihydro-9,10-dioxo- 1,5-anthra cenediyl) bis benzamide (CAS Reg. No. 82-18-8),...


(a) Identity. The color additive is 7,16-dichloro-6,15-dihydro- 5,9,14,18-anthrazinetetrone (CAS Reg. No. 130-20-1), Colour Index...


perylene-5, 10-dione. (a) Identity. The color additive is 16,17-dimethoydinaphtho[1,2,3,- cd:3',2',1'-lm]perylene-5,10-dione (CAS Reg....


copolymers. (a) Identity. The color additives are formed by reacting one or more of the reactive dyes listed in this paragraph with...


(a) Identity. The color additive is 4-[(2,4-dimethylphenyl)azo]-2,4- dihydro-5-methyl-2-phenyl-3H- pyrazol-3-one...


(2H)-one. (a) Identity. The color additive is...


(a) Identity. The color additive is phthalocyanine green (CAS Reg. No. 1328-53-6), Colour Index No. 74260. (b) Uses and restrictions. (1) The substance listed in...


(a) Identity and specifications. The color additive iron oxides (CAS Reg. No. 977053-38-5), Color Index No. 77491, shall conform in identity and specifications to the...


(a) Identity and specifications. The color additive titanium dioxide (CAS Reg. No. 13463-67-7), Color Index No. 77891, shall conform in identity and specifications to...


reaction products. (a) Identity. The color additives are formed by reacting the dyes, either alone or in combination, with a vinyl alcohol/methyl...


(a) Identity and specifications. The color additive is formed by depositing titanium or iron salts from a basic solution onto mica, followed by calcination...


Subpart A_Foods Sec. 74.101 FD&C Blue No. 1. 74.102 FD&C Blue No. 2. 74.203 FD&C Green No. 3. 74.250 Orange B. 74.302...


(a) Identity. (1) The color additive FD&C Blue No. 2 is principally the disodium salt of 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)- 2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid...


(a) Identity. (1) The color additive FD&C Green No. 3 is principally the inner salt disodium salt...


(1) The color additive Orange B is principally the disodium salt of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4- sulfonaphthylazo)-5-hydro-xypyrazole. (2) The diluents...


(a) Identity. (1) The color additive Citrus Red No. 2 is principally 1-(2,5-dimethoxyphenylazo)-2-naphthol. (2) The following diluents may be used in aqueous suspension, in...


(a) Identity. (1) The color additive FD&C Red No. 3 is principally the monohydrate of 9 (o- carboxyphenyl)-6-hydroxy - 2,4,5,7-tetraiodo- 3H-xanthen-3-one, disodium salt, with...


(a) Identity. (1) The color additive FD&C Red No. 40 is principally the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4- sulfophenyl)azo]-2-naphthalenesulfonic acid. (2)...


(a) Identity. (1) The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4- [4-sulfophenyl-azo]-1H-pyrazole-3-carboxylic acid...


(a) Identity. (1) The color additive FD&C Yellow No. 6 is principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2- naphthalenesulfonic acid (CAS Reg. No. 2783-94-0)....


(a) Identity. (1) For ingested drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of Sec. 74.101(a)(1). (2) For externally...


(a) Identity. (1) The color additive FD&C Blue No. 2 shall conform in identity to the requirements of Sec. 74.102(a)(1). (2) Color additive mixtures for use in ingested drugs...


(a) Identity. (1) The color additive D&C Blue No. 4 is principally the diammonium salt of ethyl[4-[p[ethyl(m-...


(a) Identity. The color additive D&C Blue No. 9 is principally 7,16- dichloro-6,15 - dihydro - 5,9,14,18 - anthrazine-tetrone. (b) Specifications. D&C Blue No. 9 shall conform to...


(a) Identity and specifications. (1) The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of Sec. 74.203(a)(1) and (b). ...


(a) Identity. (1) The color additive D&C Green No. 5 is principally the disodium salt of 2,2'-[(9,10-dihydro-9,10-dioxo-1,4- anthracenediyl)diimino]bis-[5-methylbenzenesulfonic...


(a) Identity. The color additive D&C Green No. 6 is 1,4-bis[(4- methylphenyl)amino]-9,10-anthracenedione (CAS. Reg. No. 128-80-3). (b) Specifications. The color additive D&C...


(a) Identity. (1) The color additive D&C Green No. 8 is principally the trisodium salt of 8-hydroxy-1,3,6-pyrene-trisulfonic acid. (2) Color additive mixtures for use in...


(a) Identity. (1) the color additive D&C Orange No. 4 is principally the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]benzenesulfonic acid. (2) Color additive mixtures...


(a) Identity. (1) the color additive D&C Orange No. 5 is a mixture consisting principally the sodium salt of 4',5'-dibromofluorescein (CAS Reg....


(a) Identity. (1) The color additive D&C Orange No. 10 is a mixture consisting principally of 4',5'-diiodofluorescein, 2',4',5'- triiodofluorescein,...


(a) Identity. (1) The color additive D&C Orange No. 11 is a mixture consisting principally of the disodium salts of 4',5'-diiodofluorescein, 2',4',5'-triiodofluorescein...


(a) Identity and specifications. (1) The color additive FD&C Red No. 3 shall conform in identity and specifications to the requirements of Sec. 74.303(a)(1) and (b). (2)...


(a) Identity. (1) The color additive FD&C Red No. 4 is principally the disodium salt of 3-[(2,4-dimethyl-5-sulfophenyl)azo] -4-hydroxy-1- naphthalenesulfonic acid. (2)...


(a) Identity. (1) The color additive D&C Red No. 6 is principally the disodium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2- naphthalenecarboxylic acid (CAS Reg. No. 5858-81-1)....


(a) Identity. (1) The color additive D&C Red No. 7 is principally the calcium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2- naphthalenecarboxylic acid (CAS Reg. No....


(a) Identity. (1) The color additive D&C Red No. 17 is principally 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol. (2) Color additive mixtures for drug use made with D&C Red No....


(a) Identity. (1) The color additive D&C Red No. 21 is principally 2',4',5',7'-tetrabromofluorescein (CAS Reg. No. 15086-94-9), and may contain smaller amounts...


(a) Identity. (1) The color additive D&C Red No. 22 is principally the disodium salt of 2',4',5'7'-tetrabromofluorescein (CAS Reg. No. 17372-87-1) and may contain smaller amounts...


(a) Identity. (1) The color additive D&C Red No. 27 is principally 2',4',5',7'-tetrabromo-4,5,6,7-tetrachlorofluorescein (CAS Reg. No. 13473-26-2). The color additive is manufactured...


(a) Identity. (1) The color additive D&C Red No. 28 is principally the disodium salt of 2',4',5',7'-tetrabromo-4,5,6,7- tetrachlorofluorescein (CAS Reg. No. 18472-87-2) formed...


(a) Identity. (1) The color additive D&C Red No. 30 is principally 6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4- methyl-benzo[b]thiophen-3(2H)-one (CAS Reg....


(a) Identity. (1) The color additive D&C Red No. 31 is principally the calcium salt of 3-hydroxy-4-(phenylazo)-2-naphthalenecarboxylic acid. (2) Color additive mixtures...


(a) Identity. (1) The color additive D&C Red No. 33 is principally the disodium salt of 5-amino-4-hydroxy-3-(phenylazo)-2,7- naphthalenedisulfonic acid (CAS Reg. No. 3567-66-6)....


(a) Identity. (1) The color additive D&C Red No. 34 is principally the calcium salt of 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2- naphthalene-carboxylic acid. (2)...


(a) Identity. (1) The color additive D&C Red No. 36 is 1-[(2-chloro- 4-nitrophenyl)azo]-2-naphthalenol (CAS Reg. No. 2814-77-9). The color additive is manufactured by diazotization...


(a) Identity. (1) The color additive D&C Red No. 39 is o- [p([beta],[beta]'-dihydroxy-diethylamino)-phenylazo]-benzoic acid. (2) Color additive mixtures made with D&C Red No....


(a) Identity and specifications. (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of Sec. 74.340(a)(1) and (b). (2)...


(a) Identity. (1) The color additive D&C Violet No. 2 is principally 1-hydroxy -4-[(4-methylphenyl)amino]-9,10-anthracenedione. (2) Color additive mixtures for use in...


(a) Identity and specifications. (1) The color additive FD&C Yellow No. 5 shall conform in identity and specifications to the requirements of Sec. 74.705 (a)(1) and (b). ...


(a) Identity and specifications. (1) The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of Sec. 74.706(a)(1) and (b). ...


(a) Identity. (1) The color additive D&C Yellow No. 7 is principally fluorescein. (2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 7...


(a) Identity. (1) The color additive Ext. D&C Yellow No. 7 is principally the disodium salt of 8-hydroxy-5,7-di-nitro-2- naphthalenesulfonic acid. (2) Color...


(a) Identity. (1) The color additive D&C Yellow No. 8 is principally the disodium salt of fluorescein. (2) Color additive mixtures for use in externally applied drugs...


(a) Identity. (1) The color additive D&C Yellow No. 10 is a mixture of the sodium salts of the mono- and disulfonic acids of 2-(2- quinolinyl)-1H-indene-1,3 (2H)-dione...


(a) Identity. (1) The color additive D&C Yellow No. 11 is principally 2-(2-quinolyl)-1,3-indandione. (2) Color additive mixtures, for drug use made with D&C Yellow No....


(a) Identity. The color additive FD&C Blue No. 1 is principally the disodium salt...


(a) Identity and specifications. The color additive D&C Blue No. 4 shall conform in identity and specifications to the requirements of Sec. 74.1104(a)(1) and...


(a) Identity. The color additive D&C Brown No. 1 is a mixture of the sodium salts of 4[[5-[(dialkylphenyl)- azo]-2,4-dihydroxyphenyl]azo]- benzene sulfonic acid. The alkyl group...


(a) Identity and specifications. The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of Sec. 74.203(a)(1) and (b). (b)...


(a) Identity and specifications. The color additive D&C Green No. 5 shall conform in identity and specifications to the requirements of Sec. 74.1205 (a)(1) and (b)(2). ...


(a) Identity and specifications. The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of Sec. 74.1206 (a) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Green No. 8 shall conform in identity and specifications to the requirements of Sec. 74.1208(a)(1) and (b). (b)...


(a) Identity and specifications. The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of Sec. 74.1254 (a)(1) and (b). (b)...


(a) Identity and specifications. The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of Sec. 74.1255 (a)(1) and (b). (b)...


(a) Identity and specifications. The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements of Sec. 74.1260(a)(1) and (b). ...


(a) Identity and specifications. The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of Sec. 74.1261(a)(1) and (b). ...


(a) Identity and specifications. The color additive FD&C Red No. 4 shall conform in identity and specifications to the requirements of Sec. 74.1304(a)(1) and (b). (b) Uses...


(a) Identity and specifications.The color additive D&C Red No. 6 shall conform in identity and specifications to the requirements of Sec. 74.1306 (a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of Sec. 74.1307 (a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of Sec. 74.1317(a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of Sec. 74.1321(a)(1) and (b). (b)...


(a) Identity and specifications. The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of Sec. 74.1322(a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of Sec. 74.1327 (a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of Sec. 74.1328 (a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of Sec. 74.1330 (a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of Sec. 74.1331(a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Red No. 33 shall conform in identity and specifications [[Page 443]] to the requirements of Sec. 74.1333(a)...


(a) Identity and specifications. The color additive D&C Red No. 34 shall conform in identity and specifications to the requirements of Sec. 74.1334(a)(1) and (b). (b) Uses...


(a) Identity and specifications. The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of Sec. 74.1336 (a)(1) and (b). (b) Uses...


(a) Identity and specifications. (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of Sec. 74.340(a)(1) and (b) of...


(a) Identity and specifications. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of Sec. 74.1602(a)(1)...


(a) Identity. The color additive Ext. D&C Violet No. 2 is principally the monosodium salt of 2-[(9,10-dihydro-4-hydroxy...


(a) Identity. The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4- sulfophenyl)azo]-1H-pyrazole-3-carboxylic...


(a) Identity and specifications. The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of Sec. 74.706 (a)(1) and (b). ...


(a) Identity and specifications. The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of Sec. 74.1707(a)(1) and (b). (b)...


(a) Identity and specifications. The color additive Ext. D&C Yellow No. 7 shall conform in identity and specifications to the requirements of Sec. 74.1707a (a)(1)...


(a) Identity and specifications. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of Sec. 74.1708(a)(1) and (b). ...


(a) Identity and specifications. The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of Sec. 74.1710(a)(1) and (b). ...


(a) Identity and specifications. The color additive D&C Yellow No. 11 shall conform in identity and specifications to the requirements of Sec. 74.1711(a)(1) and (b). ...


(a) Identity. The color additive is [phthalocyaninato(2-)] copper (CAS Reg. No. 147-14-8) having the structure shown in Colour Index No. 74160. ...


(a) Identity. The color additive FD&C Blue No. 2 shall conform in identity to the requirements of Sec. 74.102(a)(1). (b) Specifications. (1) The color additive FD&C Blue No....


(a) Identity. The color additive D&C Blue No. 6 is principally [[Delta]2,2'-biindoline]-3,3' dione (CAS Reg. No. 482-89-3). (b) Specifications. D&C Blue No....


(a) Identity. The color additive D&C Green No. 6 shall conform in identity to the requirements of Sec. 74.1206(a). (b) Specifications. The color additive D&C Green No. 6 for...


(a) Identity and specifications. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of Sec. 74.1317(a)(1) and (b). ...


(a) Identity and specifications. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of Sec. 74.1602(a)(1) and (b). ...


(a) Identity. The color additive D&C Yellow No. 10 shall conform to the identity requirements of Sec. 74.1710(a). (b) Specifications. The color additive D&C Yellow No....


Subpart A_General Provisions Sec. 80.10 Fees for certification services. Subpart B_Certification...


A request for certification of a batch of color additive shall: (a) Be addressed to the Commissioner of Food and Drugs. (b) Be prepared in the manner set forth in paragraph...


A sample of a batch of color additive which is to accompany a request for certification shall: (a) Be taken only after such batch has been so thoroughly mixed...


after such investigations as he considers to be necessary, that: (1) A request submitted in accordance with Sec. 80.21 appears to contain no untrue statement...


(a) If a certificate is obtained through fraud or misrepresentation of a material fact, such certificate shall not be effective, and a color additive from the batch on which...


(a) When it appears to the Commissioner that a person has: (1) Obtained, or attempted to obtain, a certificate through fraud or misrepresentation of a material fact. ...


certification. (a) Color additive mixtures to be certified. Any color additive mixture that contains one or more straight colors listed in part 74 of...


Immediately after the sample that is to accompany a request for certification of a batch of color additive is taken, the batch shall be: (a) Stored in containers of such...


(a) Immediately upon notification that a batch of color additive has been certified, the person requesting certification thereof shall identify such batch, by labeling,...


to whom a certificate is issued shall keep complete records showing the disposal of all the color additive from the batch covered by such certificate. Upon the request of...


of color additives. Sec. 81.1 Provisional lists of color additives. 81.10 Termination of provisional listings of color additives. 81.30 Cancellation...


provisional listings of color additives. (a) Ext. D&C Yellow Nos. 9 and 10. These colors cannot be produced with any assurance that they do not contain [beta]-naphthylamine...


certificates. (a) Certificates issued heretofore for colors being removed from the provisional list (Sec. 81.10(a)) are cancelled and of no effect after December...


Certificates issued for the color additives listed in Sec. 81.25 and for all mixtures containing these color additives are limited to the conditions stated...


Subpart A_General Provisions Sec. 82.3 Definitions. 82.5 General specifications for straight colors. 82.6...


for straight colors. No batch of a straight color listed in subpart B, C, or D shall be certified under this part unless: (a) It is free from...


(a) A batch of a mixture which contains no straight color listed in subpart C or D may be certified for use in food, drugs and cosmetics, if: (1)...


General. A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of the regulations in this part, for use in food,...


Lakes (FD&C). (a)(1) General. Any lake made by extending on a substratum of alumina, a salt prepared from one of the certified water-soluble straight colors...


FD&C Blue No. 1. The color additive FD&C Blue No. 1 shall conform in identity and specifications to the requirements of Sec. 74.101(a)(1) and (b) of...


FD&C Blue No. 2. The color additive FD&C Blue No. 2 shall conform in identity and specifications to the requirements of Sec. 74.102(a)(1) and (b) of...


FD&C Green No. 3. The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of Sec. 74.203(a)(1) and (b) of...


FD&C Red No. 4. The color additive FD&C Red No. 4 shall conform in identity and specifications to the requirements of Sec. 74.1304(a)(1) and (b) of this chapter. FD&C...


FD&C Yellow No. 5. The color additive FD&C Yellow No. 5 shall conform in identity and specifications to the requirements of Sec. 74.705 (a)(1) and (b) of...


FD&C Yellow No. 6. (a) The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of Sec. 74.706 (a)(1) and (b) of...


General. A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use only in drugs and cosmetics,...


Lakes (D&C). (a)(1) General. Any lake, other than those listed in subpart B, made by extending on a substratum of alumina, blanc fixe, gloss white, clay,...


D&C Blue No. 4. The color additive D&C Blue No. 4 shall conform in identity and specifications to the requirements of Sec. 74.1104(a)(1) and (b) of this chapter. D&C Blue...


D&C Green No. 5. The color additive D&C Green No. 5 shall conform in identity and specifications to the requirements of Sec. 74.1205(a)(1) and (b)(2) of...


D&C Green No. 6. The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of Sec. 74.1206 (a) and (b) of this chapter. D&C...


D&C Orange No. 4. The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of Sec. 74.1254(a)(1) and (b) of this chapter....


D&C Orange No. 5. (a) The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of Sec. 74.1255(a)(1) and (b) of this chapter....


D&C Orange No. 10. The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements to Sec. 74.1260(a)(1) and (b) of this chapter....


D&C Orange No. 11. The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of Sec. 74.1261(a)(1) and (b) of this chapter....


D&C Red No. 6. (a) The color additive D&C Red No. 6 shall conform in identity and specifications to the requirements of Sec. 74.1306 (a)(1) and (b) of this chapter. ...


D&C Red No. 7. (a) The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of Sec. 74.1307 (a)(1) and (b) of this chapter. ...


D&C Red No. 17. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of Sec. 74.1317 (a)(1) and (b) of this chapter. D&C Red...


D&C Red No. 21. The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of Sec. 74.1321 (a)(1) and (b) of...


D&C Red No. 22. The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of Sec. 74.1322 (a)(1) and (b) of...


D&C Red No. 27. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of Sec. 74.1327 (a)(1) and (b) of...


D&C Red No. 28. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of Sec. 74.1328 (a)(1) and (b) of...


D&C Red No. 30. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of Sec. 74.1330 (a)(1) and (b) of...


D&C Red No. 31. The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of Sec. 74.1331(a)(1) and (b) of this chapter. D&C Red...


D&C Red No. 33. (a) The color additive D&C Red. No. 33 shall conform in identity and specifications to the requirements of Sec. 74.1333(a) (1) and (b) of this chapter. ...


D&C Red No. 34. Calcium salt of 3-hydroxy-4-[(1-sulfo-2 -naph thal enyl)azol-2-naph thal ene carboxylic acid. Sum of volatile matter (at 135 [deg]C) and chlorides...


D&C Red No. 36. (a) The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of Sec. 74.1336 (a)(1) and (b) of this chapter. ...


D&C Violet No. 2. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of Sec. 74.1602(a)(1) and (b) of...


D&C Yellow No. 7. The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of Sec. 74.1707(a)(1) and (b) of this chapter....


D&C Yellow No. 8. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of Sec. 74.1707(a)(1) and (b) of this chapter....


D&C Yellow No. 10. The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of Sec. 74.1710(a)(1) and (b) of...


General. A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use in externally...


Lakes (Ext. D&C). (a)(1) General. Any lake made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc,...


Ext. D&C Yellow No. 7. The color additive Ext. D&C Yellow No. 7 shall conform in identity with specifications to the requirements of Sec. 74.1707a(a)(1) and (b)...


99.1 Scope. Subpart A_General Information Sec. 99.1 Scope. 99.3 Definitions. ...


99.3 Definitions. (a) Agency or FDA means the Food and Drug Administration. (b) For purposes of this part, a clinical investigation is an...


Sec. 99.101 Information that may be disseminated. (a) A manufacturer may disseminate written information concerning the safety, effectiveness,...


Sec. 99.103 Mandatory statements and information. (a) Any information disseminated under this part shall include: (1) A prominently displayed...


99.105 Recipients of information. A manufacturer disseminating information on a new use under this part may only disseminate that information to a...


Applications Sec. 99.201 Manufacturer's submission to the agency. (a) Sixty days before disseminating any written information concerning the...


Applications Sec. 99.203 Request to extend the time for completing planned studies. (a) A manufacturer may request, prior to or at the time of making a...


Applications Sec. 99.205 Application for exemption from the requirement to file a supplemental application. (a) In certain circumstances, described...


Applications Sec. 99.301 Agency action on a submission. (a) Submissions. Within 60 days after receiving a submission under this part, FDA may: ...


Applications Sec. 99.303 Extension of time for completing planned studies. (a) Upon review of a drug or device manufacturer's proposed protocols and schedules...


Applications Sec. 99.305 Exemption from the requirement to file a supplemental application. (a) Within 60 days after receipt of an application for...


Dissemination Sec. 99.401 Corrective actions and cessation of dissemination of information. (a) FDA actions based on post dissemination data. If...


Dissemination Sec. 99.403 Termination of approvals of applications for exemption. (a) FDA may, at any time, terminate the approval of an application for...


Dissemination Sec. 99.405 Applicability of labeling, adulteration, and misbranding authority. The dissemination of information relating to a new use for a drug...


Sec. 99.501 Recordkeeping and reports. (a) A manufacturer disseminating information under this part shall: (1) Maintain records sufficient to allow...


local requirements. (a) Scope and purpose. (1) This subpart applies to the submission and consideration of petitions under section 403A(b) of the Federal Food,...


Under section 307 of the Federal Food, Drug, and Cosmetic Act (the act), a State may bring, in its own name and within its own jurisdiction, proceedings for the civil enforcement, or...


section 403(d) of the act, a food shall be deemed to be misbranded if its container is so made, formed, or filled as to be misleading. (a) A container that does...


For the purposes of this section, the term iodized salt or iodized table salt is designated as the name of salt for human food use to which iodide has been added in the form of...


The term principal display panel as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown,...


(a) The term information panel as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by...


(a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b) Such statement...


required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by Sec. 101.100,...


required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by Sec. 101.100,...


distributor. (a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. ...


distributor. (a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. ...
...


distributor. (a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. ...
...
...


labeling in accordance with Sec. 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in Sec. 101.13 or in...


labeling in accordance with Sec. 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in Sec. 101.13 or in...
...


(a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods...


Definitions. For purposes of this section, the following definitions apply: (1) Health claim means any claim made on the label or in labeling of a food, including a...


(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 403(f)...


(a) Self-pressurized containers. (1) The label of a food packaged in a self-pressurized container and intended to be expelled from the package under pressure...


the labeling of a food which render such food misbranded is a false or misleading representation with respect to another food or a drug, device, or cosmetic. (b)...


chemical preservatives. (a)(1) The term artificial flavor or artificial flavoring means any substance, the function of which is to impart flavor, which is...


be beverages that contain fruit or vegetable juice. (a) This section applies to any food that purports to be a beverage that contains any fruit or vegetable juice...


be beverages that contain fruit or vegetable juice. (a) This section applies to any food that purports to be a beverage that contains any fruit or vegetable juice...
...


be beverages that contain fruit or vegetable juice. (a) This section applies to any food that purports to be a beverage that contains any fruit or vegetable juice...
...
...


and fish. (a) The Food and Drug Administration (FDA) urges food retailers to provide nutrition information, as provided in Sec. 101.9(c), for raw...


the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish. (a) The Food and Drug Administration (FDA) will judge a food retailer who...


raw fruit, vegetables, and fish in the United States. (a) The 20 most frequently consumed raw fruit are: Banana, apple, watermelon, orange, cantaloupe,...


of raw fruits, vegetables, and fish. (a) Nutrition labeling for raw fruits, vegetables, and fish listed in Sec. 101.44 should be presented to the public in...


``high,'' ``more,'' and ``high potency.'' Source: 58 FR 2413, Jan. 6, 1993, unless otherwise noted. (a) General requirements. Except as provided...


``lite.'' (a) General requirements. A claim using the term light or lite to describe a food may only be made on the label or in labeling of the food if: ...


content of foods. (a) General requirements. A claim about the calorie or sugar content of a food may only be made on the label or in the labeling of a food if: ...


content of foods. (a) General requirements. A claim about the level of sodium or salt in a food may only be made on the label or in the labeling of the food if: ...


content of foods. (a) General requirements. A claim about the level of sodium or salt in a food may only be made on the label or in the labeling of the food if: ...
...


related label statements. (a) General requirements. An implied nutrient content claim can only be made on the label and in labeling of the food...


(a) Claims may be made to characterize the level of nutrients, including fat, in butter if: (1) The claim complies with the requirements of Sec. 101.13...


(a) This section pertains to petitions for claims, expressed or implied, that: (1) Characterize the level of any nutrient which is of the type required to be...


(a) Any interested person may petition the Food and Drug Administration (FDA) to issue a regulation regarding a health claim. An original and one copy of the petition shall...


Health claims not authorized for foods in conventional food form or for dietary supplements of vitamins, minerals, herbs, or other similar substances: (a) Dietary...


(a) Relationship between calcium and osteoporosis. An inadequate calcium intake contributes to low peak bone mass and has been identified as one of many risk factors in...


(a) Relationship between fat and cancer. (1) Cancer is a constellation of more than 100 different diseases, each characterized by the uncontrolled growth and spread...


(a) Relationship between sodium and hypertension (high blood pressure). (1) Hypertension, or high blood pressure, generally means a systolic blood pressure of greater...


cholesterol and risk of coronary heart disease. (a) Relationship between dietary saturated fat and cholesterol and risk of coronary heart disease. (1) Cardiovascular...


fruits, and vegetables and cancer. (a) Relationship between diets low in fat and high in fiber- containing grain products, fruits, and vegetables and cancer risk....


products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. (a) Relationship between diets low in saturated fat and cholesterol and high...


cancer. (a) Relationship between substances in diets low in fat and high in fruits and vegetables and cancer risk. (1) Cancer is a constellation of more than 100...


(a) Relationship between folate and neural tube defects--(1) Definition. Neural tube defects are serious birth defects of the brain or spinal cord that can result...


sweeteners and dental caries. (a) Relationship between dietary carbohydrates and dental caries. (1) Dental caries, or tooth decay, is a disease caused by many...


and risk of coronary heart disease (CHD). (a) Relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain...


heart disease (CHD). (a) Relationship between diets that are low in saturated fat and cholesterol and that include soy protein and the risk of CHD....


risk of coronary heart disease (CHD). (a) Relationship between diets that include plant sterol/stanol esters and the risk of CHD. (1) Cardiovascular disease means...


Sec. 101.93 Certain types of statements for dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement...


Sec. 101.95 ``Fresh,'' ``freshly frozen,'' ``fresh frozen,'' ``frozen fresh.'' The terms defined in this section may be used on the label or in labeling of...


(a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name...


exempt. (a) The principal display panel of a food in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms...


conducting authorized food labeling experiments. (a) The food industry is encouraged to experiment voluntarily, under controlled conditions and in collaboration with the Food...


(a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic...


(a) 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 issue, amend,...


The common or usual name of a protein hydrolysate shall be specific to the ingredient and shall include the identity of the food source from which...


spreads. (a) The common or usual name of a spreadable peanut product that does not conform to Sec. 164.150 of this chapter, and more than 10 percent of which...


and serve'' dinners. (a) A frozen ``heat and serve'' dinner: (1) Shall contain at least three components, one of which shall be a significant source of protein...


packaged for use in the preparation of ``main dishes'' or ``dinners.'' (a) The common or usual name of a packaged food which is represented on the principal display panel...


that contain fruit or vegetable juice. (a) For a carbonated or noncarbonated beverage that contains less than 100 percent and more than 0 percent fruit or vegetable...


edible fat or oil and olive oil. The common or usual name of a mixture of edible fats and oils containing less than 100 percent and more than 0 percent olive oil...


made from diced onion. (a) The common or usual name of the food product that resembles and is of the same composition as onion rings, except that it is composed...


chips made from dried potatoes. (a) The common or usual name of the food product that resembles and is of the same composition as potato...


or portions made from minced fish. (a) The common or usual name of the food product that resembles and is of the same composition as fish sticks or fish portions,...


``Pacific whiting'' or ``North Pacific whiting'' is the common or usual name of the food fish Merluccius productus. [44 FR 45617, Aug....


``Bonito'' or ``bonito fish'' is the common or usual name of the following food fishes: Cybiosarda elegans (Whitely, 1935)--Leaping bonito Gymnosarda...


made from minced clams. (a) The common or usual name of the food product that resembles and is of the same composition as fried clams, except that it is composed...


The common or usual name of crabmeat derived from each of the following designated species of crabs shall be...


The common or usual name of a seafood cocktail in package form fabricated with one or more seafood ingredients shall be: (a) When the cocktail contains...


composite shrimp units. (a) The common on usual name of the food product that conforms to the definition and standard of identity described by Sec....


(Reinhardtius hippoglossoides). ``Greenland turbot'' is the common or usual name of the food fish Reinhardtius hippoglossoides, a species of Pleuronectidae...


(a) A nutritional quality guideline prescribes the minimum level or range [[Page 184]] of nutrient composition (nutritional quality) appropriate for a...


(a) The fundamental objective of this subpart is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods....


serve'' dinner. (a) A product, for which a common or usual name is established in Sec. 102.26 of this chapter, in order to be eligible to bear the...


The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (hereafter ``the act'') shall be applicable with...


If a food purports to be or is represented for special dietary use by reason of the decrease or absence of any allergenic property or by reason of being offered as food suitable as...


than a dietary supplement of vitamins and/or minerals alone) purports to be or is represented for special dietary use for infants, the label shall bear, if such food...


reducing or maintaining body weight. (a) General requirements. Any food that purports to be or is represented for special dietary use because of usefulness in reducing...


quality control procedures regulation. (a) The criteria set forth in Sec. Sec. 106.20, 106.25, 106.30, 106.90, and 106.100 shall apply in determining whether an...


definitions and interpretations contained in section 201 of the act are applicable to such terms when used in this part. The following definitions shall also apply: ...


Infant Formulas Sec. 106.20 Ingredient control. (a) Except as provided in Sec. 106.20(b), no analysis before use in manufacturing is needed for...


Infant Formulas Sec. 106.25 In-process control. (a) For each infant formula, a master manufacturing order shall be prepared and approved by a...


Infant Formulas Sec. 106.30 Finished product evaluation. (a) The manufacturer shall establish criteria for sampling and testing to ensure that each batch...


Infant Formulas Sec. 106.90 Coding. The manufacturer shall code all infant formulas in conformity with the coding requirements that are applicable to...


(a) Every manufacturer of infant formula shall maintain the records specified in this regulation in order to permit the Food and Drug Administration to determine whether...


reformulations. (a) Information required by section 412(b)(2) and (3) of the act shall be submitted to Center for Food Safety and Applied Nutrition (HFS- 830),...


apply, in addition to the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act): Exempt formula. An exempt infant formula is an...


infant formulas, as defined in section 201(aa) of the Federal Food, Drug, and Cosmetic Act, shall bear in the order given, in the units specified, and in tabular format,...


labeling requirements in parts 101 and 105 of this chapter, the product label shall bear: (a) Under the heading ``Directions For Preparation and Use'',...


formula, to be sold at the retail level, are contained within a multiunit package, the labels of the individual containers shall contain all of the label...


conditions. Section 412(f)(1) of the act exempts from the requirements of section 412(a), (b), and (c)(1)(A) of the act infant formulas that are represented and labeled for use...


An infant formula shall contain the following nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories...


Source: 54 FR 4008, Jan. 27, 1989, unless otherwise noted. When the Food and Drug Administration determines that an adulterated or misbranded infant...


a manufacturer has determined to recall voluntarily from the market an infant formula that is not subject to Sec. 107.200 but that otherwise violates the laws and...


(a) The requirements of this subpart apply: (1) When the Food and Drug Administration has determined that it is necessary to remove from the market a distributed infant...


A recalling firm shall conduct an infant formula recall with the following elements: (a) The recalling firm shall evaluate in writing the hazard to human health associated...


a violative infant formula. A manufacturer shall promptly notify the Food and Drug Administration when the manufacturer has knowledge (as defined in section 412(e)(2) of...


The recalling firm may submit a recommendation for termination of the recall to the appropriate Food and Drug Administration district office listed in Sec. 5.215 of this...


If after a review of the recalling firm's recall strategy or periodic reports or other monitoring of the recall, the Food and Drug Administration concludes that the actions of...


may satisfy the requirements of this subpart by any means reasonable calculated to meet the obligations set forth in this Subpart E. The recall guidance in subpart C of part...


an infant formula shall make and retain such records respecting the distribution of the infant formula through any establishment owned or operated by such manufacturer as may...


contained in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. (b) Commissioner means the Commissioner of...


(a) Whenever the Commissioner determines after investigation that a manufacturer, processor, or packer of a food for which a regulation has been promulgated in subpart B of...


(a) A permit shall be required only during such temporary period as is necessary to protect the public health. (b) Whenever the Commissioner has reason to believe...


(a) After a determination and notification by the Commissioner in accordance with the provisions of Sec. 108.5 that a manufacturer, processor, or packer requires a permit,...


(a) Whenever the Commissioner finds that a permit holder is not in compliance with the mandatory requirements and conditions established by the permit, he shall...


a permit, or in violation of a permit. (a) A manufacturer, processor, or packer may continue at his own risk to manufacture, process, or pack without a permit a food...


section 404 of the act. (a) Whenever the Commissioner finds after investigation that the distribution in interstate commerce of any class of food may, by reason...


Permit Sec. 108.25 Acidified foods. (a) Inadequate or improper manufacture, processing, or packing of acidified foods may result in the distribution...


Permit Sec. 108.35 Thermal processing of low-acid foods packaged in hermetically sealed containers. (a) Inadequate or improper manufacture, processing, or...


109.3 Definitions and interpretations. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) The definitions of terms contained in section 201 of the act...


109.4 Establishment of tolerances, regulatory limits, and action levels. (a) When appropriate under the criteria of Sec. 109.6, a tolerance for an added poisonous...


109.6 Added poisonous or deleterious substances. (a) Use of an added poisonous or deleterious substance, other than a pesticide chemical, that is also a food...


109.7 Unavoidability. (a) Tolerances and action levels in this part are established at levels based on the unavoidability of the poisonous or deleterious...


109.15 Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials. (a) Polychlorinated biphenyls (PCB's) represent a class of...


109.16 Ornamental and decorative ceramicware. (a) Lead is a toxic metal that is used as a component of glazes and decorative decals on ceramics, including...


Sec. 109.30 Tolerances for polychlorinated biphenyls (PCB's). (a) Polychlorinated biphenyls (PCB's) are toxic, industrial chemicals. Because...


110.3 Definitions. The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) are applicable to...


110.5 Current good manufacturing practice. (a) The criteria and definitions in this part shall apply in determining whether a food is adulterated (1) within the...


110.10 Personnel. The plant management shall take all reasonable measures and precautions to ensure the following: (a) Disease control. Any person who,...


110.19 Exclusions. (a) The following operations are not subject to this part: Establishments engaged solely in the harvesting, storage, or distribution of one...


110.20 Plant and grounds. (a) Grounds. The grounds about a food plant under the control of the operator shall be kept in a condition that will...


110.35 Sanitary operations. (a) General maintenance. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary...


110.37 Sanitary facilities and controls. Each plant shall be equipped with adequate sanitary facilities and accommodations including, but not limited to: ...


110.40 Equipment and utensils. (a) All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable,...


110.80 Processes and controls. All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and...


110.93 Warehousing and distribution. Storage and transportation of finished food shall be under conditions that will protect food against physical, chemical,...


110.110 Natural or unavoidable defects in food for human use that present no health hazard. (a) Some foods, even when produced under current good...


113.3 Definitions. For the purposes of this part, the following definitions apply: (a) Aseptic processing and packaging means the filling of a...


113.5 Current good manufacturing practice. The criteria in Sec. Sec. 113.10, 113.40, 113.60, 113.81, 113.83, 113.87, 113.89, and 113.100 shall apply in determining whether...


113.10 Personnel. The operators of processing systems, retorts, aseptic processing and packaging systems and product formulating systems (including systems...


113.10 Personnel. The operators of processing systems, retorts, aseptic processing and packaging systems and product formulating systems (including systems...
...


In-Process Materials Sec. 113.60 Containers. (a) Closures. Regular observations shall be maintained during...


113.81 Product preparation. (a) Before using raw materials and ingredients susceptible to microbiological contamination, the processor shall ensure that...


113.83 Establishing scheduled processes. Scheduled processes for low-acid foods shall be established by qualified persons having expert knowledge of thermal...


113.87 Operations in the thermal processing room. (a) Operating processes and retort venting procedures to be used for each product and container size being...


113.89 Deviations in processing, venting, or control of critical factors. Whenever any process is less than the scheduled process or when critical factors are out...


113.100 Processing and production records. (a) Processing and production information shall be entered at the time it is observed by the retort or processing...


this part, the following definitions apply. (a) Acid foods means foods that have a natural pH of 4.6 or below. (b) Acidified foods means low-acid foods to which acid(s) or...


in Sec. Sec. 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in part 110 of this chapter, apply in determining whether an article of acidified food...


packaging systems shall be under the operating supervisions of a person who has attended a school approved by the Commissioner for giving instruction in food-handling...


(a) Processing operations. The manufacturer shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard. (1) Acidified...


The scheduled process shall be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing...


Whenever any process operation deviates from the scheduled process for any acidified food and/or the equilibrium pH of the finished product is higher than 4.6, the...


be used to determine pH or acidity for acidified foods include, but are not limited to, the following: (a) Potentiometric method for the determination of pH--(1) Principles....


of examinations of raw materials, packaging materials, and finished products, and of suppliers' guarantees or certifications that verify compliance with Food and...


is an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption directly to consumers. (b) Except as provided...


Dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if...


(a) Any juice sold as such or used as an ingredient in beverages shall be processed in accordance with the requirements of this part. Juice means the aqueous...


The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act, Sec. 101.9(j)(18)(vi), and part 110 of this chapter are applicable to such...


practice. Part 110 of this chapter applies in determining whether the facilities, methods, practices, and controls used to process juice are safe, and...


operating procedures. (a) Sanitation controls. Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses...


(a) Each processor shall develop, or have developed for it, a written hazard analysis to determine whether there are food hazards that are reasonably likely to...


and Critical Control Point (HACCP) plan. (a) HACCP plan. Each processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more...


Failure of a processor to have and to implement a Hazard Analysis and Critical Control Point (HACCP) system that complies with Sec. Sec. 120.6, 120.7, and 120.8,...


Whenever a deviation from a critical limit occurs, a processor shall take corrective action by following the procedures set forth in paragraph (a) or...


validation. (a) Verification. Each processor shall verify that the Hazard Analysis and Critical Control Point (HACCP) system is being implemented according...


(a) Required records. Each processor shall maintain the following records documenting the processor's Hazard Analysis and Critical Control Point (HACCP) system: ...


(a) Only an individual who has met the requirements of paragraph (b) of this section shall be responsible for the following functions: (1) Developing the hazard...


requirements to imported products. This section sets forth specific requirements for imported juice. (a) Importer requirements. Every importer of juice...


[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR120.20] [Page 273] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 120_HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents Subpart B_Pathogen Reduction Sec. 120.20 General. This subpart augments subpart A of this part by setting forth specific requirements for process controls. ...


(a) In order to meet the requirements of subpart A of this part, processors of juice products shall include in their Hazard Analysis and Critical Control...


for certain processors. Each juice processor that relies on treatments that do not come into direct contact with all parts of the juice to achieve the...


interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) and in part 110 of this chapter are applicable to such terms when used in...


(a) Part 110 of this chapter applies in determining whether the facilities, methods, practices, and controls used to process fish and fishery products are safe, and whether...


Point (HACCP) plan. (a) Hazard analysis. Every processor shall conduct, or have conducted for it, a hazard analysis to determine whether there are food...


deviation from a critical limit occurs, a processor shall take corrective action either by: (1) Following a corrective action plan that is appropriate for the...


Every processor shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being...


records required by this part shall include: (1) The name and location of the processor or importer; (2) The date and time of the activity that the...


functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing at...


(a) Sanitation SOP. Each processor should have and implement a written sanitation standard operating procedure (herein referred to as SSOP) or similar document that is specific...


This section sets forth specific requirements for imported fish and fishery products. (a) Importer verification. Every importer of fish or fishery...


[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR123.15] [Page 282] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 123_FISH AND FISHERY PRODUCTS--Table of Contents Subpart B_Smoked and Smoke-Flavored Fishery Products Sec. 123.15 General. This subpart augments subpart A of this part by setting forth specific requirements for processing smoked and smoke-flavored fishery products. ...


In order to meet the requirements of subpart A of this part, processors of smoked and smoke-flavored fishery products, except those subject to the requirements of part 113 or 114 of...


subpart A of this part by setting forth specific requirements for processing fresh or frozen molluscan shellfish, where such processing does not include a treatment...


order to meet the requirements of subpart A of this part as they apply to microbiological contamination, chemical contamination, natural toxins, and related food safety...


The applicable criteria in part 110 of this chapter, as well as the criteria in Sec. Sec. 129.20, 129.35, 129.37, 129.40, and 129.80 shall apply...


For the purposes of this part, the following definitions apply: (a) Approved source when used in reference to a plant's product water or operations water means a source...


design. (a) The bottling room shall be separated from other plant operations or storage areas by tight walls, ceilings, and self-closing doors to protect...


Each plant shall provide adequate sanitary facilities including, but not limited to, the following: (a) Product water and operations water--(1) Product...


(a) The product water-contact surfaces of all multiservice containers, utensils, pipes, and equipment used in the transportation, processing, handling, and storage...


(a) Suitability. (1) All plant equipment and utensils shall be suitable for their [[Page 286]] intended use. This includes all collection...


controls. (a) Treatment of product water. All treatment of product water by distillation, ion-exchanging, filtration, ultraviolet treatment, reverse...


(a) The definitions and interpretations of terms contained in section 201 of the act shall be applicable also to such terms when used in regulations promulgated under the act. ...


(a) The procedure for establishing a food standard under section 401 of the act shall be governed by part 10 of this chapter. (b) Any petition for a food standard...


(a) All food standards adopted by the Codex Alimentarius Commission will be reviewed by the Food and Drug Administration and will be accepted without change, accepted...


In the following conditions, among others, a food does not conform to the definition and standard of identity therefor: (a) If it contains an ingredient for...


(a) Any standardized food that contains a sulfiting agent or combination of sulfiting agents that is functional and provided for in the applicable standard or that is present in...


nutrient content claim and a standardized term. (a) Description. The foods prescribed by this general definition and standard of identity are those foods that substitute...


Some definitions and standards of identity for foods set forth below require that designated optional ingredients such as spices, flavorings,...


of containers. For the purposes of regulations promulgated under section 401 of the act: (a) The term general method for water capacity of containers means...


substandard fill of container. For the purposes of regulations promulgated under section 401 of the act: (a) The term general statement of substandard quality...


experimental packs of food varying from the requirements of definitions and standards of identity. (a) The Food and Drug Administration recognizes that before petitions...


for which definitions and standards of identity are established. (a) Where a petition is received for the issuance or amendment of a regulation establishing...


milk product high in fat separated from milk, which may have been adjusted by adding thereto: Milk, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or...


The unqualified name ``whipped cream'' should not be applied to any product other than one made by whipping the cream that complies with the standards of identity...


Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Milk that is in final package form for...


(a) Description. Acidified milk is the food produced by souring one or more of the optional dairy ingredients specified in pargaph (c) of this section with one or more of the...


(a) Description. Cultured milk is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this section with characterizing...


(a) Description. Concentrated milk is the liquid food obtained by partial removal of water from milk. The milkfat and total milk solids contents of the food are not less than 7.5 and...


(a) Description. Sweetened condensed milk is the food obtained by partial removal of water only from a mixture of milk and safe and suitable nutritive carbohydrate...


Nonfat dry milk is the product obtained by removal of water only from pasteurized skim milk. It contains not more than 5 percent by weight of moisture, and not more...


A and D. (a) Description. Nonfat dry milk fortified with vitamins A and D conforms to the standard of identity for nonfat dry milk, except that vitamins A and...


(a) Description. Evaporated milk is the liquid food obtained by partial removal of water only from milk. It contains not less than 6.5 percent by weight of milkfat, not less than...


(a) Description. Dry whole milk is the product obtained by removal of water only from pasteurized milk, as defined in Sec. 131.110(a), which may have been homogenized. Alternatively,...


cream is the product obtained by removal of water only from pasteurized milk or cream or a mixture thereof, which may have been homogenized. Alternatively, dry cream may...


Heavy cream is cream which contains not less than 36 percent milkfat. It is pasteurized or ultra-pasteurized, and may be homogenized. (b) Optional ingredients....


cream is cream which contains not less than 18 percent but less than 30 percent milkfat. It is pasteurized or ultra- pasteurized, and may be homogenized. ...


(a) Description. Light whipping cream is cream which contains not less than 30 percent but less than 36 percent milkfat. It is pasteurized or ultra-pasteurized, and may...


Sour cream results from the souring, by lactic acid producing bacteria, of pasteurized cream. Sour cream contains not less than 18 percent milkfat; except that when the...


(a) Description. Acidified sour cream results from the souring of pasteurized cream with safe and suitable acidifiers, with or without addition of lactic acid producing...


is the food containing one or more of the optional dairy ingredients specified in paragraph (b), one or more of the optional egg yolk-containing ingredients specified...


(a) Description. Half-and-half is the food consisting of a mixture of milk and cream which contains not less than 10.5 percent but less than 18 percent milkfat. It is pasteurized...


is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this section with a characterizing bacterial culture...


(a) Description. Lowfat yogurt is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this section with a characterizing...


(a) Description. Nonfat yogurt is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this section with a characterizing...


means the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows, which may be clarified and may be adjusted by...


Moisture, milkfat, and phosphatase levels in cheeses will be determined by the following methods of analysis from ``Official Methods of Analysis of the Association of Official...


distributors of pasteurized blended cheese, pasteurized process cheese, cheese food, cheese spread, and related foods. (a) Definitions and standards...


Products Sec. 133.102 Asiago fresh and asiago soft cheese. (a) Asiago fresh cheese, asiago soft cheese, is the food prepared from milk and other...


Products Sec. 133.103 Asiago medium cheese. Asiago medium cheese conforms to the definition and standard of identity and is subject to the requirements for...


Products Sec. 133.104 Asiago old cheese. Asiago old cheese conforms to the definition and standard of identity and is subject to the requirements for label...


Products Sec. 133.106 Blue cheese. (a) Description. (1) Blue cheese is the food prepared by the procedure set forth in paragraph (a)(2), of this section, or...


Products Sec. 133.108 Brick cheese. (a) Description. (1) Brick cheese is the food prepared from dairy ingredients and other ingredients specified in this...


Products Sec. 133.109 Brick cheese for manufacturing. Brick cheese for manufacturing conforms to the definition and standard of identity for brick cheese...


Products Sec. 133.111 Caciocavallo siciliano cheese. (a) Caciocavallo siciliano cheese is the food prepared from cow's milk or sheep's milk or goat's milk...


Products Sec. 133.113 Cheddar cheese. (a) Description. (1) Cheddar cheese is the food prepared by the procedure set forth in paragraph (a)(3) of this section,...


Products Sec. 133.114 Cheddar cheese for manufacturing. Cheddar cheese for manufacturing conforms to the definition and standard of identity prescribed for...


Products Sec. 133.116 Low sodium cheddar cheese. Low sodium cheddar cheese is the food prepared from the same ingredients and in the same manner prescribed in Sec....


Products Sec. 133.118 Colby cheese. (a) Colby cheese is the food prepared from milk and other ingredients specified in this section, by the procedure set forth...


Products Sec. 133.119 Colby cheese for manufacturing. Colby cheese for manufacturing conforms to the definition and standard of identity prescribed for colby...


Products Sec. 133.121 Low sodium colby cheese. Low sodium colby cheese is the food prepared from the same ingredients and in the same manner prescribed in Sec....


Products Sec. 133.123 Cold-pack and club cheese. (a)(1) Cold-pack cheese, club cheese, is the food prepared by comminuting, without the aid of heat, one or...


Products Sec. 133.124 Cold-pack cheese food. (a)(1) Cold-pack cheese food is the food prepared by comminuting and mixing, without the aid of heat, one or more...


Products Sec. 133.125 Cold-pack cheese food with fruits, vegetables, or meats. (a) Cold-pack cheese food with fruits, vegetables, or meats or mixtures of these is...


Products Sec. 133.127 Cook cheese, koch kaese. (a) Description. (1) Cook cheese, koch kaese, is the food prepared by the procedure set forth in paragraph...


Products Sec. 133.128 Cottage cheese. (a) Cottage cheese is the soft uncured cheese prepared by mixing cottage cheese dry curd with a creaming mixture as...


Products Sec. 133.129 Dry curd cottage cheese. (a) Cottage cheese dry curd is the soft uncured cheese prepared by the procedure set forth in paragraph (b) of...


Products Sec. 133.133 Cream cheese. (a) Description. (1) Cream cheese is the soft, uncured cheese prepared by the procedure set forth in paragraph (a)(2) of...


Products Sec. 133.134 Cream cheese with other foods. (a) Description. Cream cheese with other foods is the class of foods prepared by mixing, with or without...


Products Sec. 133.136 Washed curd and soaked curd cheese. (a) Description. (1) Washed curd, soaked curd cheese is the food prepared by the procedure set forth...


Products Sec. 133.137 Washed curd cheese for manufacturing. Washed curd cheese for manufacturing conforms to the definition and standard of identity prescribed...


Products Sec. 133.138 Edam cheese. (a) Description. (1) Edam cheese is the food prepared by the procedure set forth in paragraph (a)(3) of this section or by...


Products Sec. 133.140 Gammelost cheese. (a) Description. (1) Gammelost cheese is the food prepared from nonfat milk, as defined in Sec. 133.3, by the...


Products Sec. 133.141 Gorgonzola cheese. (a) Description. (1) Gorgonzola cheese is the food prepared by the procedure set forth in paragraph (a)(2) of...


Products Sec. 133.142 Gouda cheese. Gouda cheese conforms to the definition and standard of identity and complies with the requirements for label declaration...


Products Sec. 133.144 Granular and stirred curd cheese. (a) Description. (1) Granular cheese, stirred curd cheese is the food prepared by the procedure set...


Products Sec. 133.145 Granular cheese for manufacturing. Granular cheese for manufacturing conforms to the definition and standard of identity prescribed for...


Products Sec. 133.146 Grated cheeses. (a) Description. Grated cheeses is the class of foods prepared by grinding, grating, shredding, or otherwise...


Products Sec. 133.147 Grated American cheese food. (a)(1) Grated American cheese food is the food prepared by mixing, with or without the aid of heat, one or...


Products Sec. 133.148 Hard grating cheeses. (a) The cheeses for which definitions and standards of identity are prescribed by this section are hard...


Products Sec. 133.149 Gruyere cheese. (a) Description. (1) Gruyere cheese is the food prepared by the procedure set forth in paragraph (a)(3) of this section or...


Products Sec. 133.150 Hard cheeses. (a) The cheeses for which definitions and standards of identity are prescribed by this section are hard cheeses for...


Products Sec. 133.152 Limburger cheese. (a) Description. (1) Limburger cheese is the food prepared by one of the procedures set forth in paragraph (a)(3) of...


Products Sec. 133.153 Monterey cheese and monterey jack cheese. (a) Description. (1) Monterey cheese, monterey jack cheese is the food prepared by the...


Products Sec. 133.154 High-moisture jack cheese. High-moisture jack cheese conforms to the definition and standard of identity and is subject to the requirement...


Products Sec. 133.155 Mozzarella cheese and scamorza cheese. (a) Description. (1) Mozzarella cheese, scamorza cheese is the food prepared from dairy...


Products Sec. 133.156 Low-moisture mozzarella and scamorza cheese. (a) Description. (1) Low-moisture mozzarella cheese, low-moisture scamorza cheese is the...


Products Sec. 133.157 Part-skim mozzarella and scamorza cheese. Part-skim mozzarella cheese, part-skim scamorza cheese conforms to the definition and standard...


Products Sec. 133.158 Low-moisture part-skim mozzarella and scamorza cheese. Low-moisture part-skim mozzarella cheese and low-moisture part-skim scamorza...


Products Sec. 133.160 Muenster and munster cheese. (a) Description. (1) Muenster cheese, munster cheese, is the food prepared by the procedure set forth...


Products Sec. 133.161 Muenster and munster cheese for manufacturing. Muenster cheese for manufacturing conforms to the definition and standard of identity...


Products Sec. 133.162 Neufchatel cheese. (a) Description. (1) Neufchatel cheese is the soft uncured cheese prepared by the procedure set forth in paragraph...


Products Sec. 133.164 Nuworld cheese. (a) Description. (1) Nuworld cheese is the food prepared by the procedure set forth in paragraph (a)(2) of this section...


Products Sec. 133.165 Parmesan and reggiano cheese. (a) Parmesan cheese, reggiano cheese, is the food prepared from milk and other ingredients specified in...


Products Sec. 133.167 Pasteurized blended cheese. Pasteurized blended cheese conforms to the definition and standard of identity, and is subject to the...


Products Sec. 133.168 Pasteurized blended cheese with fruits, vegetables, or meats. (a) Pasteurized blended cheese with fruits, vegetables, or meats, or mixtures...


Products Sec. 133.169 Pasteurized process cheese. (a)(1) Pasteurized process cheese is the food prepared by comminuting and mixing, with the aid of heat, one...


Products Sec. 133.170 Pasteurized process cheese with fruits, vegetables, or meats. (a) Unless a definition and standard of identity specifically applicable...


Products Sec. 133.171 Pasteurized process pimento cheese. Pasteurized process pimento cheese is the food which conforms to the definition and standard of identity...


Products Sec. 133.173 Pasteurized process cheese food. (a)(1) A pasteurized process cheese food is the food prepared by comminuting and mixing, with the aid...


Products Sec. 133.174 Pasteurized process cheese food with fruits, vegetables, or meats. (a) Pasteurized process cheese food with fruits, vegetables, or meats,...


Products Sec. 133.175 Pasteurized cheese spread. Pasteurized cheese spread is the food which conforms to the definition and standard of identity, and is subject...


Products Sec. 133.176 Pasteurized cheese spread with fruits, vegetables, or meats. (a) Pasteurized cheese spread with fruits, vegetables, or meats, or mixtures...


Products Sec. 133.178 Pasteurized neufchatel cheese spread with other foods. (a)(1) Pasteurized neufchatel cheese spread with other foods is the class of foods...


Products Sec. 133.179 Pasteurized process cheese spread. (a)(1) Pasteurized process cheese spread is the food prepared by comminuting and mixing, with the aid...


Products Sec. 133.180 Pasteurized process cheese spread with fruits, vegetables, or meats. (a) Pasteurized process cheese spread with fruits, vegetables,...


Products Sec. 133.181 Provolone cheese. (a) Description. (1) Provolone, a pasta filata or stretched curd- type cheese, is the food prepared by the procedure...


Products Sec. 133.182 Soft ripened cheeses. (a) The cheeses for which definitions and standards of identity are prescribed by this section are soft...


Products Sec. 133.183 Romano cheese. (a) Romano cheese is the food prepared from cow's milk or sheep's milk or goat's milk or mixtures of two or all of these...


Products Sec. 133.184 Roquefort cheese, sheep's milk blue-mold, and blue-mold cheese from sheep's milk. (a) Description. (1) Roquefort cheese, sheep's milk...


Products Sec. 133.185 Samsoe cheese. (a) Description. (1) Samsoe cheese is the food prepared by the procedure set forth in paragraph (a)(3) of this section or by...


Products Sec. 133.186 Sap sago cheese. (a) Description. (1) Sap sago cheese is the food prepared by the procedure set forth in paragraph (a)(2) of this section...


Products Sec. 133.187 Semisoft cheeses. (a) The cheeses for which definitions and standards of identity are prescribed by this section are semisoft cheeses...


Products Sec. 133.188 Semisoft part-skim cheeses. (a) The cheeses for which definitions and standards of identity are prescribed by this section are...


Products Sec. 133.189 Skim milk cheese for manufacturing. (a) Skim milk cheese for manufacturing is the food prepared from skim milk and other...


Products Sec. 133.190 Spiced cheeses. (a) Description. (1) Spiced cheeses are cheeses for which specifically applicable definitions and standards of identity...


Products Sec. 133.191 Part-skim spiced cheeses. Part-skim spiced cheeses conform to the definition and standard of identity, and are subject to the requirements...


Products Sec. 133.193 Spiced, flavored standardized cheeses. (a) Except as otherwise provided for herein and in applicable sections in this part, a spiced or...


Products Sec. 133.195 Swiss and emmentaler cheese. (a) Description. (1) Swiss cheese, emmentaler cheese, is the food prepared by the procedure set forth...


Products Sec. 133.196 Swiss cheese for manufacturing. Swiss cheese for manufacturing conforms to the definition and standard of identity prescribed for...


a pasteurized mix is one in which every particle of the mix has been heated in properly operated equipment to one of the temperatures specified in the table in this section...


(a) Description. (1) Ice cream is a food produced by freezing, while stirring, a pasteurized mix consisting of one or more of the optional dairy ingredients...


(a) Description. Goat's milk ice cream is the food prepared in the same manner prescribed in Sec. 135.110 for ice cream, and complies with all the provisions of Sec....


(1) Mellorine is a food produced by freezing, while stirring, a pasteurized mix consisting of safe and suitable ingredients including, but not limited to, milk-derived...


(1) Sherbet is a food produced by freezing, while stirring, a pasteurized mix consisting of one or more of the optional dairy ingredients specified in paragraph (b) of...


ices are the foods each of which is prepared from the same ingredients and in the same manner prescribed in Sec. 135.140 for sherbets, except that the mix need not...


the following definitions apply: (a) The word bread when used in the name of the food means the unit weighs one-half pound or more after cooling. (b) The words rolls...


(a) Bread, white bread, and rolls, white rolls, or buns, and white buns are the foods produced by baking mixed yeast-leavened dough prepared from one or more of...


(a) Each of the foods enriched bread, enriched rolls, and enriched buns conforms to the definition and standard of identity and is subject to the requirements for...


(a) Each of the foods milk bread, milk rolls, and milk buns conforms to the definition and standard of identity and is subject to the requirements for label statement...


(a) Each of the foods raisin bread, raisin rolls, and raisin buns conforms to the definition and standard of identity and is subject to the requirements for...


(a) Each of the foods whole wheat bread, graham bread, entire wheat bread, whole wheat rolls, graham rolls, entire wheat rolls, whole wheat buns, graham buns, and...


Related Products Sec. 137.105 Flour. (a) Flour, white flour, wheat flour, plain flour, is the food prepared by grinding and bolting cleaned wheat, other...


Sec. 137.155 Bromated flour. Bromated flour conforms to the definition and standard of identity, and is subject to the requirements for label statement...


Sec. 137.160 Enriched bromated flour. Enriched bromated flour conforms to the definition and standard of identity, and is subject to the requirements...


Related Products Sec. 137.165 Enriched flour. Enriched flour conforms to the definition and standard of identity, and is subject to the requirements for...


Sec. 137.170 Instantized flours. (a) Instantized flours, instant blending flours, and quick-mixing flours, are the foods each of which conforms to...


Sec. 137.175 Phosphated flour. Phosphated flour, phosphated white flour, and phosphated wheat flour, conform to the definition and standard of...


Related Products Sec. 137.180 Self-rising flour. (a) Self-rising flour, self-rising white flour, self-rising wheat flour, is an intimate mixture of flour,...


Sec. 137.185 Enriched self-rising flour. Enriched self-rising flour conforms to the definition and standard of identity, and is subject to...


Related Products Sec. 137.190 Cracked wheat. Cracked wheat is the food prepared by so cracking or cutting into angular fragments cleaned wheat other than durum...


Sec. 137.195 Crushed wheat. Crushed wheat, coarse ground wheat, is the food prepared by so crushing cleaned wheat other than durum wheat and red...


Related Products Sec. 137.200 Whole wheat flour. (a) Whole wheat flour, graham flour, entire wheat flour is the food prepared by so grinding cleaned wheat, other...


Sec. 137.205 Bromated whole wheat flour. Bromated whole wheat flour conforms to the definition and standard of identity, and is subject to...


Related Products Sec. 137.211 White corn flour. (a) White corn flour is the food prepared by so grinding and bolting cleaned white corn that when tested by the...


Sec. 137.215 Yellow corn flour. Yellow corn flour conforms to the definition and standard of identity prescribed by Sec. 137.211 for white corn...


Sec. 137.220 Durum flour. (a) Durum flour is the food prepared by grinding and bolting cleaned durum wheat. When tested for granulation as prescribed...


Sec. 137.225 Whole durum flour. Whole durum wheat flour conforms to the definition and standard of identity, and is subject to the requirements for...


Related Products Sec. 137.250 White corn meal. (a) White corn meal is the food prepared by so grinding cleaned white corn that when tested by the method prescribed...


Sec. 137.255 Bolted white corn meal. (a) Bolted white corn meal is the food prepared by so grinding and sifting cleaned white corn that: (1)...


Related Products Sec. 137.260 Enriched corn meals. (a) Enriched corn meals are the foods, each of which conforms to the definition and standard of identity...


Sec. 137.265 Degerminated white corn meal. (a) Degerminated white corn meal, degermed white corn meal, is the food prepared by grinding cleaned white...


Related Products Sec. 137.270 Self-rising white corn meal. (a) Self-rising white corn meal is an intimate mixture of white corn meal, sodium bicarbonate, and one...


Sec. 137.275 Yellow corn meal. Yellow corn meal conforms to the definition and standard of identity prescribed by Sec. 137.250 for white corn meal...


Sec. 137.280 Bolted yellow corn meal. Bolted yellow corn meal conforms to the definition and standard of identity prescribed by Sec. 137.255 for...


Sec. 137.285 Degerminated yellow corn meal. Degerminated yellow corn meal, degermed yellow corn meal, conforms to the definition and standard of...


Sec. 137.290 Self-rising yellow corn meal. Self-rising yellow corn meal conforms to the definition and standard of identity prescribed by Sec....


Related Products Sec. 137.300 Farina. (a) Farina is the food prepared by grinding and bolting cleaned wheat, other than durum wheat and red durum wheat, to...


Related Products Sec. 137.305 Enriched farina. (a) Enriched farina conforms to the definition and standard of identity prescribed for farina by Sec. 137.300,...


Sec. 137.320 Semolina. (a) Semolina is the food prepared by grinding and bolting cleaned durum wheat to such fineness that, when tested by the...


Related Products Sec. 137.350 Enriched rice. (a) The foods for which definitions and standards of identity are prescribed by this section are forms of milled...


Products Sec. 139.110 Macaroni products. (a) Macaroni products are the class of food each of which is prepared by drying formed units of dough made from...


Products Sec. 139.115 Enriched macaroni products. (a) Description. Enriched macaroni products are the class of food each of which conforms to the definition...


Products Sec. 139.117 Enriched macaroni products with fortified protein. (a)(1) Each of the foods for which a standard of identity is prescribed by this section...


Products Sec. 139.120 Milk macaroni products. (a) Milk macaroni products are the class of food, each of which conforms to the definition and standard of identity and...


139.121 Nonfat milk macaroni products. (a) Each of the macaroni products made with nonfat milk for which a definition and standard of identity is...


Products Sec. 139.122 Enriched nonfat milk macaroni products. (a) Each of the enriched macaroni products made with nonfat milk for which a definition and standard...


139.125 Vegetable macaroni products. (a) Vegetable macaroni products are the class of food each of which conforms to the definition and standard of...


Products Sec. 139.135 Enriched vegetable macaroni products. (a) Each of the macaroni products for which a definition and standard of identity is prescribed by...


139.138 Whole wheat macaroni products. (a) Whole wheat macaroni products are the class of food each of which conforms to the definition and standard...


Products Sec. 139.140 Wheat and soy macaroni products. (a) Wheat and soy macaroni products are the class of food each of which conforms to the definition and...


Products Sec. 139.150 Noodle products. (a) Noodle products are the class of food each of which is prepared by drying formed units of dough made from semolina,...


139.155 Enriched noodle products. (a) Enriched noodle products are the class of food each of which conforms to the definition and standard of identity, and...


Products Sec. 139.160 Vegetable noodle products. (a) Vegetable noodle products are the class of food each of which conforms to the definition and standard of...


139.165 Enriched vegetable noodle products. (a) Each of the noodle products for which a definition and standard of identity is prescribed by this...


Products Sec. 139.180 Wheat and soy noodle products. (a) Wheat and soy noodle products are the class of food each of which conforms to the definition and standard...


part: (a) The term corn sirup means a clarified, concentrated aqueous solution of the products obtained by the incomplete hydrolysis of cornstarch, and includes dried...


(a) Identity--(1) Definition. Canned applesauce is the food prepared from comminuted or chopped apples (Malus domestica Borkhausen), which may or may not be peeled and cored,...


(a) Identity--(1) Ingredients. Canned apricots is the food prepared from mature apricots of one of the optional styles specified in paragraph (a)(2) of this section, which may be packed...


(a) Artificially sweetened canned apricots is the food which conforms to the definition and standard of identity prescribed for canned apricots by Sec....


Identity--(1) Ingredients. Canned berries is the food prepared from any suitable variety of one of the optional berry ingredients specified in paragraph (a)(2) of this section,...


(a) Identity--(1) Ingredients. Canned cherries is the food prepared from one of the optional fresh or previously canned cherry ingredients specified in paragraph (a)(2) of this...


(a) Artificially sweetened canned cherries is the food which conforms to the definition and standard of identity prescribed for canned cherries by Sec....


Canned figs is the food prepared from one of the optional fig ingredients specified in paragraph (b) of this section and one of the optional packing media specified...


(a) Artificially sweetened canned figs is the food which conforms to the definition and standard of identity prescribed for canned figs by Sec. 145.130, except that in...


(a) Canned preserved figs is the food prepared from one of the optional fig ingredients specified in paragraph (b) of this section and the packing medium specified in paragraph...


(a) Identity--(1) Ingredients. Canned fruit cocktail, canned cocktail fruits, canned fruits for cocktail, is the food prepared from the mixture of fresh, frozen, or previously...


cocktail. (a) Artificially sweetened canned fruit cocktail is the food which conforms to the definition and standard of identity prescribed for canned fruit cocktail...


(a) Ingredients. Canned seedless grapes is the food prepared from one of the fresh or previously canned optional grape ingredients specified in paragraph (b) of this section...


(a) Identity--(1) Product identification. Canned grapefruit is the food prepared from one of the optional grapefruit ingredients specified in paragraph (a)(2) of this section and one...


Identity--(1) Ingredients. Canned peaches is the food prepared from one of the fresh, frozen, or previously canned optional peach ingredients Prunus persica L., of commercial...


(a) Artificially sweetened canned peaches is the food which conforms to the definition and standard of identity prescribed for canned peaches by Sec....


Ingredients. Canned pears is the food prepared from one of the fresh or previously canned optional pear ingredients Pyrus communis or Pyrus sinensis specified in...


(a) Artificially sweetened canned pears is the food which conforms to the definition and standard of identity prescribed for canned pears by Sec. 145.175(a)...


(a) Identity--(1) Ingredients. Canned pineapple is the food prepared from mature, fresh or previously canned, pineapple conforming to the characteristics of Ananas comosus (L.)...


(a) Artificially sweetened canned pineapple is the food that conforms to the definition and standard of identity prescribed for canned pineapple by Sec....


Ingredients. Canned plums is the food prepared from clean, sound, and mature fruit of plum varieties conforming to the characteristics of Prunus domestica L.,...


Canned prunes is the food prepared from dried prunes, which may be packed as a solid pack or in one of the optional packing media specified in paragraph (b) of this...


this part: (a) The term corn sirup means a clarified, concentrated, aqueous solution of the products obtained by the incomplete hydrolysis of cornstarch, and includes...


146.114 Lemon juice. (a) Identity--(1) Description. Lemon juice is the unfermented juice, obtained by mechanical process, from sound, mature lemons...


146.120 Frozen concentrate for lemonade. (a) Frozen concentrate for lemonade is the frozen food prepared from one or both of the lemon juice...


146.121 Frozen concentrate for artificially sweetened lemonade. (a) Frozen concentrate for artificially sweetened lemonade conforms to the definition and...


146.126 Frozen concentrate for colored lemonade. (a) Frozen concentrate for colored lemonade conforms to the definition and standard of identity prescribed...


146.132 Grapefruit juice. (a) Identity--(1) Description. Grapefruit juice is the unfermented juice, intended for direct consumption, obtained by...


146.135 Orange juice. (a) Orange juice is the unfermented juice obtained from mature oranges of the species Citrus sinensis or of the citrus hybrid...


146.137 Frozen orange juice. (a) Frozen orange juice is orange juice as defined in Sec. 146.135, except that it is frozen. (b) The name of the food...


146.140 Pasteurized orange juice. (a) Pasteurized orange juice is the food prepared from unfermented juice obtained from mature oranges as specified in Sec....


146.141 Canned orange juice. (a) Canned orange juice is the food prepared from orange juice as specified in Sec. 146.135 or frozen orange juice as specified...


146.145 Orange juice from concentrate. (a) Orange juice from concentrate is the food prepared by mixing water with frozen concentrated orange juice as...


146.146 Frozen concentrated orange juice. (a) Frozen concentrated orange juice is the food prepared by removing water from the juice of mature oranges...


146.148 Reduced acid frozen concentrated orange juice. (a) Reduced acid frozen concentrated orange juice is the food that complies with the requirements...


146.150 Canned concentrated orange juice. (a) Canned concentrated orange juice is the food that complies with the requirements of composition, definition...


146.151 Orange juice for manufacturing. (a) Orange juice for manufacturing is the food prepared for further manufacturing use. It is prepared from...


146.152 Orange juice with preservative. (a) Orange juice with preservative is the food prepared for further manufacturing use. It complies with the requirements...


146.153 Concentrated orange juice for manufacturing. (a) Concentrated orange juice for manufacturing is the food that complies with the requirements of...


146.154 Concentrated orange juice with preservative. (a) Concentrated orange juice with preservative complies with the requirements for composition and...


146.185 Pineapple juice. (a) Identity. (1) Pineapple juice is the juice, intended for direct consumption, obtained by mechanical process from the flesh or...


146.187 Canned prune juice. (a) Canned prune juice is the food prepared from a water extract of dried prunes and contains not less than 18.5 percent by...


Preserves, and Related Products Sec. 150.110 Fruit butter. (a) The fruit butters for which definitions and standards of identity are...


Preserves, and Related Products Sec. 150.140 Fruit jelly. (a) The jellies for which definitions and standards of identity are prescribed by...


Preserves, and Related Products Sec. 150.141 Artificially sweetened fruit jelly. (a) The artificially sweetened fruit jellies for which...


Preserves, and Related Products Sec. 150.160 Fruit preserves and jams. (a) The preserves or jams for which definitions and standards of identity...


Preserves, and Related Products Sec. 150.161 Artificially sweetened fruit preserves and jams. (a) The artificially sweetened fruit preserves...


(a) Identity. (1) Frozen cherry pie (excluding baked and then frozen) is the food prepared by incorporating in a filling contained in a pastry shell mature, pitted, stemmed...


this part: (a) The procedure for determining drained weight is set forth in the ``Official Methods of Analysis of the Association of Official Analytical Chemists,'' 13th...


wax beans. (a) Identity--(1) Definition. Canned green beans and canned wax beans are the foods prepared from succulent pods of fresh green bean or wax bean...


(a) Identity--(1) Definition. Canned sweet corn is the product prepared from clean, sound kernels of sweet corn packed with a suitable liquid packing medium which may include water...


(a) Identity. (1) Canned field corn conforms to the definition and standard of identity, and is subject to the requirements for label declaration of ingredients, prescribed for...


(a) Identity--(1) Definition. Canned peas is the food prepared from fresh or frozen succulent seeds of the pea plant of the species Pisum sativum L. but excluding the...


(a) Identity. Canned dry peas conforms to the definition and standard of identity, and is subject to the requirements for label declaration of ingredients, prescribed for canned...


(a) Identity--(1) Description. (i) Canned tomatoes is the food prepared from mature tomatoes conforming to the characteristics of the fruit Lycopersicum esculentum P. Mill, of red...


(a) Identity--(1) Definition. Tomato concentrates are the class of foods each of which is prepared by concentrating one or any combination of two or more of the...


Definition. Catsup, ketchup, or catchup is the food prepared from one or any combination of two or more of the following optional tomato ingredients: (i)...


(a) The canned vegetables for which definitions and standards of identity are prescribed by this section are those named in column I of the table set forth...


(a) Identity--(1) Definition. Canned mushrooms is the food properly prepared from the caps and stems of succulent mushrooms conforming to the characteristics of the species...


this part: (a) Strength and redness of color means at least as much red as obtained by comparison of the prepared product, with the blended color produced by spinning...


(a) Identity--(1) Definition. Tomato juice is the food intended for direct consumption, obtained from the unfermented liquid extracted from mature tomatoes of the red or...


this part the following definitions shall apply: (a) Lot. A collection of primary containers or units of the same size, type and style manufactured or packed under...


(a) Identity--(1) Product definition. Frozen peas is the food in ``package'' form as that term is defined in Sec. 1.20 of this chapter, prepared from the succulent seed of the...


[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR160.100] [Page 493] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 160_EGGS AND EGG PRODUCTS--Table of Contents Subpart B_Requirements for Specific Standardized Eggs and Egg Products Sec. 160.100 Eggs. No regulation shall be promulgated fixing and establishing a reasonable definition and standard of identity for the food commonly known as eggs. ...


(a) Dried eggs, dried whole eggs are prepared by drying liquid eggs that conform to Sec. 160.115, with such precautions that the finished food is free of viable...


(a) Frozen eggs, frozen whole eggs, frozen mixed eggs is the food prepared by freezing liquid eggs that conform to Sec. 160.115, with such precautions that the finished food...


(a) Liquid eggs, mixed eggs, liquid whole eggs, mixed whole eggs are eggs of the domestic hen broken from the shells and with yolks and whites in their natural proportion as so...


(a) Egg whites, liquid egg whites, liquid egg albumen is the food obtained from eggs of the domestic hen, broken from the shells and separated from yolks. The food may be mixed,...


(a) The food dried egg whites, egg white solids, dried egg albumen, egg albumen solids is prepared by drying liquid egg whites conforming to the requirements of Sec....


(a) Frozen egg whites, frozen egg albumen is the food prepared by freezing liquid egg whites that conform to [[Page 497]] Sec. 160.140, with such...


(a) Egg yolks, liquid egg yolks, yolks, liquid yolks are yolks of eggs of the domestic hen so separated from the whites thereof as to contain not less than 43 percent total egg...


(a) Dried egg yolks, dried yolks is the food prepared by drying egg yolks that conform to Sec. 160.180, with such precautions that the finished food is free of...


(a) Frozen egg yolks, frozen yolks is the food prepared by freezing egg yolks that conform to Sec. 160.180, with such precautions that the finished food is free of...


oysters. (a) For many years packers of canned oysters in the Gulf area of the United States have labeled their output with a declaration of the drained weight...


(a) Oysters, raw oysters, shucked oysters, are the class of foods each of which is obtained by shucking shell oysters and preparing them in accordance with the procedure prescribed...


Olympia oysters, raw Olympia oysters, shucked Olympia oysters, are of the species Ostrea lurida and conform to the definition and standard of identity prescribed for oysters in Sec....


(a) Identity. (1) Canned oysters is the food prepared from one or any mixture of two or all of the forms of oysters specified in paragraph (a)(2) of this section, and a...


(a) Identity. (1) Canned Pacific salmon is the food prepared from one of the species of fish enumerated in paragraph (a)(2) of this section, prepared in one of the forms...


transparent or nontransparent containers. (a) Identity. (1) Canned wet pack shrimp is the food consisting of the processed meat of peeled shrimp, free of heads and, to...


(a) Frozen raw breaded shrimp is the food prepared by coating one of the optional forms of shrimp specified in paragraph (c) of this section with safe and suitable...


Frozen raw lightly breaded shrimp complies with the provisions of Sec. 161.175, except that it contains not less than 65 percent of shrimp material, as determined...


Frozen raw lightly breaded shrimp complies with the provisions of Sec. 161.175, except that it contains not less than 65 percent of shrimp material, as determined...
...


content in cacao products shall be determined by the following methods of analysis prescribed in ``Official Methods of Analysis of the Association of Official Analytical...


(a) Description. (1) Cacao nibs is the food prepared by removing the shell from cured, cleaned, dried, and cracked cacao beans. The cacao shell content is not more than 1.75 percent...


(a) Description. (1) Chocolate liquor is the solid or semiplastic food prepared by finely grinding cacao nibs. The fat content of the food may be adjusted by adding one or more of...


(a) Description. (1) Breakfast cocoa is the food prepared by pulverizing the material remaining after part of the cacao fat has been removed from ground cacao nibs. Breakfast...


is the food that conforms to the definition and standard of identity, and is subject to the requirements for label declaration of ingredients for breakfast cocoa in Sec....


Lowfat cocoa is the food that conforms to the definition and standard of identity, and is subject to the requirements for label declaration of ingredients for breakfast...


manufacturing. (a) Description. Cocoa with dioctyl sodium sulfosuccinate for manufacturing is the food additive complying with the provisions prescribed in Sec....


(a) Description. (1) Sweet chocolate is the solid or semiplastic food prepared by intimately mixing and grinding chocolate liquor with one or more optional nutritive...


(a) Description. (1) White chocolate is the solid or semiplastic food prepared by intimately mixing and grinding cacao fat with one or more of the optional dairy ingredients specified...


(a) Description. (1) Milk chocolate is the solid or semiplastic food prepared by intimately mixing and grinding chocolate liquor with one or more of the optional dairy ingredients and...


(a) Description. Buttermilk chocolate is the food that conforms to the standard of identity, and is subject to the requirements for label declaration of ingredients for milk...


(a) Description. Skim milk chocolate is the food that conforms to the standard of identity, and is subject to the requirements for label declaration of ingredients for milk chocolate...


(a) Description. Mixed dairy product chocolates are the foods that conform to the standard of identity, and are subject to the requirements for label declaration...


(a) Description. Sweet cocoa and vegetable fat coating is the food that conforms to the definition and standard of identity, and is subject to the requirements...


(a) Description. Sweet chocolate and vegetable fat coating is the food that conforms to the definition and standard of identity, and is subject to the...


(a) Description. Milk chocolate and vegetable fat coating is the food that conforms to the standard of identity, and is subject to the requirements for...


Products Sec. 164.110 Mixed nuts. (a) Mixed nuts is the food consisting of a mixture of four or more of the optional shelled tree nut ingredients, with or...


Products Sec. 164.120 Shelled nuts in rigid or semirigid containers. (a)-(b) [Reserved] (c) Fill of container. (1) The standard of fill for shelled nuts...


164.150 Peanut butter. (a) Peanut butter is the food prepared by grinding one of the shelled and roasted peanut ingredients provided for by paragraph (b)...


of determining quality factors related to manufacture, processing, or packing, a collection of primary containers or units of the same size, type, and style produced...


of determining quality factors related to manufacture, processing, or packing, a collection of primary containers or units of the same size, type, and style produced...
...


Drug, and Cosmetic Act was amended by Pub. L. 459, 81st Congress (64 Stat. 20) on colored oleomargarine or margarine by adding thereto a new section numbered 407. Among other...


(or oleomargarine) is the food in plastic form or liquid emulsion, containing not less than 80 percent fat determined by the method prescribed in ``Official Methods...


168.110 Dextrose anhydrous. (a) Dextrose anhydrous is purified and crystallized D-glucose without water of crystallization and conforms to...


Sirups Sec. 168.111 Dextrose monohydrate. (a) Dextrose monohydrate is purified and crystallized D-glucose containing one molecule of water of crystallization with...


168.120 Glucose sirup. (a) Glucose sirup is the purified, concentrated, aqueous solution of nutritive saccharides obtained from edible starch. (b)...


168.121 Dried glucose sirup. (a) Dried glucose sirup is glucose sirup from which the water has been partially removed and conforms to the specifications of...


168.122 Lactose. (a) Lactose is the carbohydrate normally obtained from whey. It may be anhydrous or contain one molecule of water of crystallization or be...


168.130 Cane sirup. (a) Cane sirup is the liquid food derived by concentration and heat treatment of the juice of sugarcane (Saccharum officinarum L.) or...


Sirups Sec. 168.140 Maple sirup. (a) Maple sirup is the liquid food derived by concentration and heat treatment of the sap of the maple tree (Acer) or by solution...


168.160 Sorghum sirup. (a) Sorghum sirup is the liquid food derived by concentration and heat treatment of the juice of sorghum cane (sorgos) (Sorghum...


Sirups Sec. 168.180 Table sirup. (a) Table sirup is the liquid food consisting of one or more of the optional sweetening ingredients provided for in paragraph (b)(1)...


purposes of this part: (a) The term vanilla beans means the properly cured and dried fruit pods of Vanilla planifolia Andrews and of Vanilla tahitensis Moore. (b) The...


Sec. 169.115 French dressing. (a) Description. French dressing is the separable liquid food or the emulsified viscous fluid food prepared from...


169.140 Mayonnaise. (a) Description. Mayonnaise is the emulsified semisolid food prepared from vegetable oil(s), one or both of the...


Sec. 169.150 Salad dressing. (a) Description. Salad dressing is the emulsified semisolid food prepared from vegetable oil(s), one or both of the...


Sec. 169.175 Vanilla extract. (a) Vanilla extract is the solution in aqueous ethyl alcohol of the sapid and odorous principles extractable from vanilla...


169.176 Concentrated vanilla extract. (a) Concentrated vanilla extract conforms to the definition and standard of identity and is subject to any...


169.177 Vanilla flavoring. (a) Vanilla flavoring conforms to the definition and standard of identity and is subject to any requirement for label statement...


169.178 Concentrated vanilla flavoring. (a) Concentrated vanilla flavoring conforms to the definition and standard of identity and is subject to...


Sec. 169.179 Vanilla powder. (a) Vanilla powder is a mixture of ground vanilla beans or vanilla oleoresin or both, with one or more of the following...


169.180 Vanilla-vanillin extract. (a) Vanilla-vanillin extract conforms to the definition and standard of identity and is subject to any requirement...


169.181 Vanilla-vanillin flavoring. (a) Vanilla-vanillin flavoring conforms to the definition and standard of identity and is subject to any requirement...


169.182 Vanilla-vanillin powder. (a) Vanilla-vanillin powder conforms to the definition and standard of identity and is subject to any requirement for...


Subpart A_General Provisions Sec. 170.3 Definitions. 170.6 Opinion letters on food additive status. 170.10 Food additives in standardized foods. 170.15 Adoption...


(a) Over the years the Food and Drug Administration has given informal written opinions to inquiries as to the [[Page 10]] safety of articles intended for use as...


(a) The inclusion of food ingredients in parts 170 through 189 of this chapter does not imply that these ingredients may be used in standardized foods unless they are recognized...


(a) The Commissioner upon his own initiative may propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions...


to market edible products from experimental animals. A food additive or food containing a food additive intended for investigational use by...


(a) Food additives that cause similar or related pharmacological effects will be regarded as a class, and in the absence of evidence to the contrary, as having additive toxic effects...


pesticide chemical residues occur in processed foods due to the use of raw agricultural commodities that bore or contained a pesticide chemical in conformity with an exemption...


(a) In reaching a decision on any petition filed under section 409 of the Act, the Commissioner will give full consideration to the specific...


with section 409(c)(5)(C) of the Act, the following [[Page 13]] safety factors will be applied in determining whether the proposed use of a food additive will...


safe (GRAS). (a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety...


(a) The Commissioner, either on his initiative or on the petition of an interested person, may affirm the GRAS status of substances that directly or indirectly...


(a) The Commissioner may, in accordance with Sec. 170.35(b)(4) or (c)(5), publish a notice in the Federal Register determining that a substance is not GRAS and is a food additive...


(a) A substance used in a food-contact article (e.g., food-packaging or food-processing equipment) that migrates, or that may be expected to...


The Commissioner of Food and Drugs has concluded that it is in the interest of the public health to limit the addition of fluorine compounds to foods (a) to that resulting...


consumption. (a) Heretofore, the Food and Drug Administration has expressed the opinion in trade correspondence that glycine is generally recognized as safe...


(a) Nitrites and/or nitrates are food additives when combined in curing premixes with spices and/or other flavoring or seasoning ingredients that contain or constitute...


contact substance (FCN) to the Food and Drug Administration (FDA). Source: 67 FR 35729, May 21, 2002, unless otherwise noted. (a) An FCN is effective for...


substance (FCN). An FCN must contain the following: (a) A comprehensive discussion of the basis for the manufacturer's or supplier's determination that...


for a food contact substance (FCN). (a) During the 120-day period of the Food and Drug Administration (FDA) review of an FCN, FDA will not disclose publicly...


a food contact substance (FCN). A manufacturer or supplier may withdraw an FCN without prejudice to a future submission to the Food and Drug Administration...


(FCN). (a) If the Food and Drug Administration (FDA) does not object to an FCN within the 120-day period for FDA review, the FCN becomes effective. (b) If...


a premarket notification for a food contact substance (FCN) is no longer effective. (a) If data or other information available to FDA, including...


(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...


Subpart A_General Provisions Sec. 171.1 Petitions. 171.6 Amendment of petition. 171.7 Withdrawal of petition without prejudice. 171.8 Threshold of...


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...


(a) In some cases the Commissioner will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or...


articles. Substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate or that may be expected to migrate into...


(a) The Commissioner will forward for publication in the Federal Register, within 90 days after filing of the petition (or within 180 days if the time is extended...


[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR171.102] [Page 29] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 171_FOOD ADDITIVE PETITIONS--Table of Contents Subpart B_Administrative Actions on Applications Sec. 171.102 Effective date of regulation. A regulation published in accordance with Sec. 171.100(a) shall become effective upon publication in the Federal Register. ...


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...


or exemptions from tolerances. (a) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this...


General provisions for direct food additives. Subpart A_General Provisions Sec. 172.5 General provisions for direct...


Anoxomer. Anoxomer as identified in this section may be safely used in accordance with the following conditions: (a) Anoxomer is...


BHA. The food additive BHA (butylated hydroxyanisole) alone or in combination with other antioxidants permitted in food for human consumption in this subpart...


BHT. The food additive BHT (butylated hydroxytoluene), alone or in combination with other antioxidants permitted in this subpart B may be safely used in or...


Calcium disodium EDTA. The food additive calcium disodium EDTA (calcium disodium ethylene- diaminetetraacetate) may be safely used in designated foods for...


Dehydroacetic acid. The food additive dehydroacetic acid and/or its sodium salt may be safely used in accordance with the following prescribed conditions: ...


Dimethyl dicarbonate. Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in food in accordance with the following prescribed conditions: ...


Disodium EDTA. The food additive disodium EDTA (disodium ethylenediaminetetraace tate) may be safely used in designated foods for the purposes and...


Ethoxyquin. (a) Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may be safely used as an antioxidant for preservation of color in the production...


Heptylparaben. (a) The food additive heptylparaben is the chemical n-heptyl p- hydroxybenzoate. (b) It may be safely used to inhibit microbiological spoilage...


4-Hydroxymethyl-2,6-di-tert-butylphenol. The food additive 4-hydroxymethyl-2,6-di-tert-butylphenol may be safely used in food in accordance with the...


Natamycin (pimaricin). (a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is a polyene macrolide antimycotic substance possessing an...


Potassium nitrate. The food additive potassium nitrate may be safely used as a curing agent in the processing of cod roe, in an amount not to exceed 200 parts...


Quaternary ammonium chloride combination. The food additive, quaternary ammonium chloride combination, may be safely used in food in accordance with the...


Sodium nitrate. The food additive sodium nitrate may be safely used in or on specified foods in accordance with the following prescribed conditions: (a)...


Sodium nitrite. The food additive sodium nitrite may be safely used in or on specified foods in accordance with the following prescribed conditions: (a) It...


Sodium nitrite used in processing smoked chub. The food additive sodium nitrite may be safely used in combination with salt (NaCl) to aid in inhibiting...


Stannous chloride. The food additive stannous chloride may be safely used for color retention in asparagus packed in glass, with lids lined with an...


TBHQ. The food additive TBHQ, which is the chemical 2-(1,1-dimethylethyl)- 1,4-benzenediol (Chemical Abstracts Service Registry Number 1948-33-0), also known...


THBP. The food additive THBP (2,4,5-trihydroxybutyrophenone) may be safely used in food in accordance with the following prescribed conditions: (a) The...


172.210 Coatings on fresh citrus fruit. Coatings may be applied to fresh citrus fruit for protection of the fruit in accordance with the...


172.215 Coumarone-indene resin. The food additive coumarone-indene resin may be safely used on grapefruit, lemons, limes, oranges, tangelos, and tangerines...


172.225 Methyl and ethyl esters of fatty acids produced from edible fats and oils. Methyl esters and ethyl esters of fatty acids produced from edible...


172.230 Microcapsules for flavoring substances. Microcapsules may be safely used for encapsulating discrete particles of flavoring substances that are...


172.235 Morpholine. Morpholine may be safely used as a component of food, subject to the following restrictions. (a) It is used as the salt(s) of one or...


172.250 Petroleum naphtha. Petroleum naphtha may be safely used in food in accordance with the following conditions: (a) The additive is a mixture...


172.255 Polyacrylamide. Polyacrylamide containing not more than 0.2 percent of acrylamide monomer may be safely used as a film former in the imprinting...


172.260 Oxidized polyethylene. Oxidized polyethylene may be safely used as a component of food, subject to the following restrictions: (a)...


172.270 Sulfated butyl oleate. Sulfate butyl oleate may be safely used in food, subject to the following prescribed conditions: (a) The additive is...


172.275 Synthetic paraffin and succinic derivatives. Synthetic paraffin and succinic derivatives identified in this section may be safely used as a component...


172.280 Terpene resin. The food additive terpene resin may be safely used in accordance with the following prescribed conditions: (a) The food additive...


172.310 Aluminum nicotinate. Aluminum nicotinate may be safely used as a source of niacin in foods for special dietary use. A statement of the...


172.315 Nicotinamide-ascorbic acid complex. Nicotinamide-ascorbic acid complex may be safely used in accordance with the following prescribed conditions: ...


172.320 Amino acids. The food additive amino acids may be safely used as nutrients added to foods in accordance with the following conditions: (a)...


172.325 Bakers yeast protein. Bakers yeast protein may be safely used in food in accordance with the following conditions: (a) Bakers yeast protein is...


172.330 Calcium pantothenate, calcium chloride double salt. The food additive calcium chloride double salt of calcium pantothenate may be safely used in...


172.335 D-Pantothenamide. The food additive D-pantothenamide as a source of pantothenic acid activity, may be safely used in foods for special dietary use in...


172.340 Fish protein isolate. (a) The food additive fish protein isolate may be safely used as a food supplement in accordance with the following...


172.345 Folic acid (folacin). Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate, may be safely used in food as a nutrient in accordance...


172.350 Fumaric acid and salts of fumaric acid. Fumaric acid and its calcium, ferrous, magnesium, potassium, and sodium salts may be safely used in food...


172.365 Kelp. Kelp may be safely added to a food as a source of the essential mineral iodine, provided the maximum intake of the food as may be...


172.370 Iron-choline citrate complex. Iron-choline citrate complex made by reacting approximately equimolecular quantities of ferric hydroxide, choline, and...


172.372 N-Acetyl-L-methionine. The food additive N-acetyl-L-methionine may be safely added to food (except infant foods and foods containing...


172.375 Potassium iodide. The food additive potassium iodide may be safely used in accordance with the following prescribed conditions: (a)...


172.380 Vitamin D3. The food additive may be used safely in foods as a nutrient supplement defined under Sec. 170.3(o)(20) of this chapter...


172.385 Whole fish protein concentrate. The food additive whole fish protein concentrate may be safely used as a food supplement in accordance with...


172.395 Xylitol. Xylitol may be safely used in foods for special dietary uses, provided the amount used is not greater than that required to produce...


172.399 Zinc methionine sulfate. Zinc methionine sulfate, CAS Reg. No. 56329-42-1, may be safely used in accordance with the following prescribed conditions: ...


Calcium silicate. Calcium silicate, including synthetic calcium silicate, may be safely used in food in accordance with the following...


Iron ammonium citrate. Iron ammonium citrate may be safely used in food in accordance with the following prescribed conditions: (a) The additive is...


Silicon dioxide. The food additive silicon dioxide may be safely used in food in accordance with the following conditions: (a) The food additive...


Yellow prussiate of soda. (a) The food additive yellow prussiate of soda (sodium ferrocyanide decahydrate;...


172.510 Natural flavoring substances and natural substances used in conjunction with flavors. Natural flavoring substances and natural adjuvants may...


172.515 Synthetic flavoring substances and adjuvants. Synthetic flavoring substances and adjuvants may be safely used in food in accordance with the...


172.520 Cocoa with dioctyl sodium sulfosuccinate for manufacturing. The food additive ``cocoa with dioctyl sodium sulfosuccinate for manufacturing,'' conforming...


172.530 Disodium guanylate. Disodium guanylate may be safely used as a flavor enhancer in foods, at a level not in excess of that reasonably required to produce...


172.535 Disodium inosinate. The food additive disodium inosinate may be safely used in food in accordance with the following prescribed conditions: (a)...


172.540 DL-Alanine. DL-Alanine (a racemic mixture of D- and L-alanine; CAS Reg. No. 302- 72-7) may be safely used as a flavor enhancer for sweeteners in...


172.560 Modified hop extract. The food additive modified hop extract may be safely used in beer in accordance with the following prescribed conditions: ...


172.575 Quinine. Quinine, as the hydrochloride salt or sulfate salt, may be safely used in food in accordance with the...


172.580 Safrole-free extract of sassafras. The food additive safrole-free extract of sassafras may be safely used in accordance with the following...


172.585 Sugar beet extract flavor base. Sugar beet extract flavor base may be safely used in food in accordance with the provisions of this section. ...


172.590 Yeast-malt sprout extract. Yeast-malt sprout extract, as described in this section, may be safely used in food in accordance with the following...


172.610 Arabinogalactan. Arabinogalactan may be safely used in food in accordance with the following conditions: (a) Arabinogalactan is...


172.615 Chewing gum base. The food additive chewing gum base may be safely used in the manufacture of chewing gum in accordance with the following...


172.620 Carrageenan. The food additive carrageenan may be safely used in food in accordance with the following prescribed conditions: (a) The...


172.623 Carrageenan with polysorbate 80. Carrageenan otherwise meeting the definition and specifications of Sec. 172.620 (a) and (b) and salts of...


172.626 Salts of carrageenan. The food additive salts of carrageenan may be safely used in food in accordance with the following prescribed conditions: ...


172.655 Furcelleran. The food additive furcelleran may be safely used in food in accordance with the following prescribed conditions: (a) The...


172.660 Salts of furcelleran. The food additive salts of furcelleran may be safely used in food in accordance with the following prescribed conditions: ...


172.665 Gellan gum. The food additive gellan gum may be safely used in food in accordance with the following prescribed conditions: (a) The...


172.695 Xanthan gum. The food additive xanthan gum may be safely used in food in accordance with the following prescribed conditions: (a) The...


172.710 Adjuvants for pesticide use dilutions. The following surfactants and related adjuvants may be safely added to pesticide use dilutions by a grower...


172.712 1,3-Butylene glycol. The food additive 1,3-butylene glycol (CAS Reg. No. 107-88-0) may be safely used in food in accordance with the following...


172.715 Calcium lignosulfonate. Calcium lignosulfonate may be safely used in or on food, subject to the provisions of this section. (a) Calcium...


172.720 Calcium lactobionate. The food additive calcium lactobionate may be safely used in food in accordance with the following prescribed conditions: (a)...


172.723 Epoxidized soybean oil. Epoxidized soybean oil may be safely used in accordance with the following prescribed conditions: (a) The additive is prepared...


172.725 Gibberellic acid and its potassium salt. The food additives gibberellic acid and its potassium salt may be used in the malting of barley in accordance...


172.730 Potassium bromate. The food additive potassium bromate may be safely used in the malting of barley under the following prescribed conditions: (a)(1)...


172.735 Glycerol ester of wood rosin. Glycerol ester of wood rosin may be safely used in food in accordance with the following prescribed conditions: (a) It...


172.755 Stearyl monoglyceridyl citrate. The food additive stearyl monoglyceridyl citrate may be safely used in food in accordance with the following provisions: ...


172.765 Succistearin (stearoyl propylene glycol hydrogen succinate). The food additive succistearin (stearoyl propylene glycol hydrogen succinate) may be safely used...


172.770 Ethylene oxide polymer. The polymer of ethylene oxide may be safely used as a foam stabilizer in fermented malt beverages in accordance with the...


172.775 Methacrylic acid-divinylbenzene copolymer. Methacrylic acid-divinylbenzene copolymer may be safely used in food in accordance with the following...


172.800 Acesulfame potassium. Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as acesulfame K, may be safely used as a general-purpose sweetener...


Acetone peroxides. The food additive acetone peroxides may be safely used in flour, and in bread and rolls where standards of identity do not preclude its...


172.804 Aspartame. The food additive aspartame may be safely used in food in accordance with good manufacturing practice as a sweetening agent and a flavor...


Azodicarbonamide. The food additive azodicarbonamide may be safely used in food in accordance with the following prescribed conditions: (a) It is used...


172.808 Copolymer condensates of ethylene oxide and propylene oxide. Copolymer condensates of ethylene oxide and propylene oxide may be safely used in food under...


172.809 Curdlan. Curdlan may be safely used in accordance with the following conditions: (a) Curdlan is a high molecular weight polymer of...


Dioctyl sodium sulfo suc cinate. The food additive dioctyl sodium sulfosuccinate, which meets the specifications of the Food Chemicals Codex, 3d Ed. (1981),...


172.811 Glyceryl tristearate. The food additive glyceryl tristearate may be safely used in food in accordance with the following prescribed conditions: (a)...


Glycine. The food additive glycine may be safely used for technological purposes in food in accordance with the following prescribed conditions: (a)...


Hydroxylated lecithin. The food additive hydroxylated lecithin may be safely used as an emulsifier in foods in accordance with the following conditions: ...


Methyl glucoside-coconut oil ester. Methyl glucoside-coconut oil ester may be safely used in food in accordance with the following conditions: (a) It is...


Oxystearin. The food additive oxystearin may be safely used in foods, when such use is not precluded by standards of identity in accordance with the...


172.820 Polyethylene glycol (mean molecular weight 200-9,500). Polyethylene glycol identified in this section may be safely used in food in accordance with the...


172.822 Sodium lauryl sulfate. The food additive sodium lauryl sulfate may be safely used in food in accordance with the following conditions: (a) The...


Sodium mono- and dimethyl naphthalene sulfonates. The food additive sodium mono- and dimethyl naphthalene sulfonates may be safely used in accordance with...


Sodium stearyl fumarate. Sodium stearyl fumarate may be safely used in food in accordance with the following conditions: (a) It contains not less than...


172.828 Acetylated monoglycerides. The food additive acetylated monoglycerides may be safely used in or on food in accordance with the following...


Neotame. (a) Neotame is the chemical N-[N-(3,3-dimethylbutyl)-L-[alpha]- aspartyl]-L-phenylalanine-1-methyl ester (CAS Reg. No. 165450-17-9). (b)...


Succinylated monoglycerides. The food additive succinylated monoglycerides may be safely used in food in accordance with the following prescribed conditions: ...


172.831 Sucralose. (a) Sucralose is the chemical 1,6-dichloro-1,6-dideoxy-[beta]-D- fructofuranosyl-4-chloro-4-deoxy-[alpha]-D-galactopyranoside (CAS Reg....


Monoglyceride citrate. A food additive that is a mixture of glyceryl monooleate and its citric acid monoester manufactured by the reaction of...


172.833 Sucrose acetate isobutyrate (SAIB). Sucrose acetate isobutyrate may be safely used in foods in accordance with the following prescribed conditions: ...


Ethoxylated mono- and diglycerides. The food additive ethoxylated mono-and diglycerides (polyoxyethylene (20) mono- and diglycerides of fatty acids)...


172.836 Polysorbate 60. The food additive polysorbate 60 (polyoxyethylene (20) sorbitan monostearate) which is a mixture of polyoxyethylene ethers of mixed...


172.838 Polysorbate 65. The food additive polysorbate 65 (polyoxyethylene (20) sorbitan tristearate), which is a mixture of polyoxyethylene ethers of mixed...


172.840 Polysorbate 80. The food additive polysorbate 80 (polyoxyethylene (20) sorbitan monooleate), which is a mixture of polyoxyethylene ethers of mixed...


Polydextrose. Polydextrose as identified in this section may be safely used in food in accordance with the following prescribed conditions: ...


172.842 Sorbitan monostearate. The food additive sorbitan monostearate, which is a mixture of partial stearic and palmitic acid esters of sorbitol anhydrides, may...


Calcium stearoyl-2-lactylate. The food additive calcium stearoyl-2-lactylate may be safely used in or on food in accordance with the following...


172.846 Sodium stearoyl lactylate. The food additive sodium stearoyl lactylate (CAS Reg. No. 25-383- 997) may be safely used in food in accordance with the...


Lactylic esters of fatty acids. Lactylic esters of fatty acids may be safely used in food in accordance with the following prescribed conditions: (a)...


Lactylated fatty acid esters of glycerol and propylene glycol. The food additive lactylated fatty acid esters of glycerol and propylene glycol may be...


Glyceryl-lacto esters of fatty acids. Glyceryl-lacto esters of fatty acids (the lactic acid esters of mono- and diglycerides) may be safely used in food...


172.854 Polyglycerol esters of fatty acids. Polyglycerol esters of fatty acids, up to and including the decaglycerol esters, may be safely used in food in accordance...


Propylene glycol mono- and diesters of fats and fatty acids. Propylene glycol mono- and diesters of fats and fatty acids may be safely used in food, subject to...


172.858 Propylene glycol alginate. The food additive propylene glycol alginate (CAS Reg. No. 9005-37-2) may be used as an emulsifier, flavoring adjuvant, formulation...


172.859 Sucrose fatty acid esters. Sucrose fatty acid esters identified in this section may be safely used in accordance with the following prescribed conditions: ...


172.860 Fatty acids. The food additive fatty acids may be safely used in food and in the manufacture of food components in accordance with the following...


Cocoa butter substitute from coconut oil, palm kernel oil, or both oils. The food additive, cocoa butter substitute from coconut oil, palm kernel oil, or...


172.862 Oleic acid derived from tall oil fatty acids. The food additive oleic acid derived from tall oil fatty acids may be safely used in food and as a component in...


Salts of fatty acids. The food additive salts of fatty acids may be safely used in food and in the manufacture of food components in accordance with...


172.864 Synthetic fatty alcohols. Synthetic fatty alcohols may be safely used in food and in the synthesis of food components in accordance with the following...


Synthetic glycerin produced by the hydrogenolysis of carbohydrates. Synthetic glycerin produced by the hydrogenolysis of carbohydrates may be safely used in...


172.867 Olestra. Olestra, as identified in this section, may be safely used in accordance with the following conditions: (a) Olestra is a mixture of...


Ethyl cellulose. The food additive ethyl cellulose may be safely used in food in accordance with the following prescribed conditions: (a) The food...


172.869 Sucrose oligoesters. Sucrose oligoesters, as identified in this section, may be safely used in accordance with the following conditions: (a)...


Hydroxypropyl cellulose. The food additive hydroxypropyl cellulose may be safely used in food, except standardized foods that do not provide for such use,...


Methyl ethyl cellulose. The food additive methyl ethyl cellulose may be safely used in food in accordance with the following prescribed conditions. (a)...


172.874 Hydroxypropyl methylcellulose. The food additive hydroxypropyl methylcellulose (CAS Reg. No. 9004- 65-3) may be safely used in food, except in standardized...


Castor oil. The food additive castor oil may be safely used in accordance with the following conditions: (a) The additive meets the specifications of...


172.878 White mineral oil. White mineral oil may be safely used in food in accordance with the following conditions: (a) White mineral oil is a mixture...


Petrolatum. Petrolatum may be safely used in food, subject to the provisions of this section. (a) Petrolatum complies with the specifications set forth...


172.882 Synthetic isoparaffinic petroleum hydrocarbons. Synthetic isoparaffinic petroleum hydrocarbons may be safely used in food, in accordance with the...


Odorless light petroleum hydrocarbons. Odorless light petroleum hydrocarbons may be safely used in food, in accordance with the following...


Odorless light petroleum hydrocarbons. Odorless light petroleum hydrocarbons may be safely used in food, in accordance with the following...
...


Synthetic petroleum wax. Synthetic petroleum wax may be safely used in or on foods in accordance with the following conditions: (a) Synthetic petroleum...


Rice bran wax. Rice bran wax may be safely used in food in accordance with the following conditions: (a) It is the refined wax obtained from rice bran...


172.892 Food starch-modified. Food starch-modified as described in this section may be safely used in food. The quantity of any substance employed to effect...


Modified cottonseed products intended for human consumption. The food additive modified cottonseed products may be used for human consumption in accordance with...


Dried yeasts. Dried yeast (Saccharomyces cerevisiae and Saccharomyces fragilis) and dried torula yeast (Candida utilis) may be safely used in food provided...


172.898 Bakers yeast glycan. Bakers yeast glycan may be safely used in food in accordance with the following conditions: (a) Bakers yeast glycan is...


Sec. 173.5 Acrylate-acrylamide resins. Subpart A_Polymer Substances and Polymer Adjuvants for Food...


173.10 Modified polyacrylamide resin. Modified polyacrylamide resin may be safely used in food in accordance with the following prescribed conditions: ...


Sec. 173.20 Ion-exchange membranes. Ion-exchange membranes may be safely used in the processing of food under the following prescribed conditions: ...


173.21 Perfluorinated ion exchange membranes. Substances identified in paragraph (a) of this section may be safely used as ion exchange membranes...


Sec. 173.25 Ion-exchange resins. Ion-exchange resins may be safely used in the treatment of food under the following prescribed conditions: (a)...


173.40 Molecular sieve resins. Molecular sieve resins may be safely used in the processing of food under the following prescribed conditions: (a)...


173.45 Polymaleic acid and its sodium salt. Polymaleic acid (CAS Reg. No. 26099-09-2) and its sodium salt (CAS Reg. No. 70247-90-4) may be safely used...


173.50 Polyvinylpolypyrrolidone. The food additive polyvinylpoly pyrrolidone may be safely used in accordance with the following prescribed conditions: ...


173.55 Polyvinylpyrrolidone. The food additive polyvinylpyrroli-done may be safely used in accordance with the following prescribed conditions: ...


Sec. 173.60 Dimethylamine-epichlorohydrin copolymer. Dimethylamine-epichlorohydrin copolymer (CAS Reg. No. 25988-97-0) may be safely used in food...


173.65 Divinylbenzene copolymer. Divinylbenzene copolymer may be used for the removal of organic substances from aqueous foods under the following...


173.70 Chloromethylated aminated styrene-divinylbenzene resin. Chloromethylated aminated styrene-divinylbenzene copolymer (CAS Reg. No. 60177-39-1) may...


173.73 Sodium polyacrylate. Sodium polyacrylate (CAS Reg. No. 9003-04-7) may be safely used in food in accordance with the following...


173.75 Sorbitan monooleate. Sorbitan monooleate may be safely used in accordance with the following prescribed conditions: (a) The additive...


173.110 Amyloglucosidase derived from Rhizopus niveus. Amyloglucosidase enzyme product, consisting of enzyme derived from Rhizopus niveus, and diatomaceous...


173.115 Alpha-acetolactate decarboxylase ([alpha]-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis. The food additive...


173.120 Carbohydrase and cellulase derived from Aspergillus niger. Carbohydrase and cellulase enzyme preparation derived from Aspergillus niger may be safely used...


173.130 Carbohydrase derived from Rhizopus oryzae. Carbohydrase from Rhizopus oryzae may be safely used in the production of dextrose from starch in accordance...


173.135 Catalase derived from Micrococcus lysodeikticus. Bacterial catalase derived from Micrococcus lysodeikticus by a pure culture fermentation process may be...


173.140 Esterase-lipase derived from Mucor miehei. Esterase-lipase enzyme, consisting of enzyme derived from Mucor miehei var. Cooney et Emerson by a pure...


173.145 Alpha-Galactosidase derived from Mortierella vinaceae var. raffinoseutilizer. The food additive alpha-galactosidase and parent mycelial...


173.150 Milk-clotting enzymes, microbial. Milk-clotting enzyme produced by pure-culture fermentation process may be safely used in the production of cheese...


173.160 Candida guilliermondii. The food additive Candida guilliermondii may be safely used as the organism for fermentation production of citric acid in...


173.165 Candida lipolytica. The food additive Candida lipolytica may be safely used as the organism for fermentation production of citric acid in accordance...


173.170 Aminoglycoside 3'-phospho trans ferase II. The food additive aminoglycoside 3'-phosphotransferase II may be safely used in the development of...


173.210 Acetone. A tolerance of 30 parts per million is established for acetone in spice oleoresins when present therein as a residue from...


173.220 1,3-Butylene glycol. 1,3-Butylene glycol (1,3-butanediol) may be safely used in food in accordance with the following prescribed conditions: ...


173.228 Ethyl acetate. Ethyl acetate (CAS Reg. No. 141-78-6) may be safely used in food in accordance with the following conditions: (a)...


173.230 Ethylene dichloride. A tolerance of 30 parts per million is established for ethylene dichloride in spice oleoresins when present therein as...


173.240 Isopropyl alcohol. Isopropyl alcohol may be present in the following foods under the conditions specified: (a) In spice oleoresins as...


173.250 Methyl alcohol residues. Methyl alcohol may be present in the following foods under the conditions specified: (a) In spice oleoresins as...


173.255 Methylene chloride. Methylene chloride may be present in food under the following conditions: (a) In spice oleoresins as a residue from...


173.270 Hexane. Hexane may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from...


173.275 Hydrogenated sperm oil. The food additive hydrogenated sperm oil may be safely used in accordance with the following prescribed conditions: ...


Sec. 173.280 Solvent extraction process for citric acid. A solvent extraction process for recovery of citric acid from...


173.290 Trichloroethylene. Tolerances are established for residues of trichloroethylene resulting from its use as a solvent in the manufacture of foods...


173.300 Chlorine dioxide. Chlorine dioxide (CAS Reg. No. 10049-04-4) may be safely used in food in accordance with the following prescribed conditions: ...


173.310 Boiler water additives. Boiler water additives may be safely used in the preparation of steam that will contact food, under the following conditions: ...


173.315 Chemicals used in washing or to assist in the peeling of fruits and vegetables. Chemicals may be safely used to wash or to assist in the peeling of...


173.320 Chemicals for controlling microorganisms in cane-sugar and beet-sugar mills. Agents for controlling microorganisms in cane-sugar and beet-sugar mills may...


Chemicals used in delinting cottonseed. Chemicals may be safely used to assist in the delinting of cottonseed in accordance with the following conditions: ...


173.325 Acidified sodium chlorite solutions. Acidified sodium chlorite solutions may be safely used in accordance with the following prescribed conditions: ...


173.340 Defoaming agents. Defoaming agents may be safely used in processing foods, in accordance with the following conditions: (a) They consist of one or more...


Chlorofluorocarbon 113 and perfluorohexane. A mixture of 99 percent chlorofluorocarbon 113 (1,1,2-trichloro- 1,2,2-trifluoroethane) (CAS Reg. No. 76-13-1, also...


Chloropentafluoroethane. The food additive chloropentafluoroethane may be safely used in food in accordance with the following prescribed conditions: (a)...


173.350 Combustion product gas. The food additive combustion product gas may be safely used in the processing and packaging of the foods designated in paragraph (c)...


Dichlorodifluoromethane. The food additive dichlorodi fluoromethane may be safely used in food in accordance with the following prescribed conditions: (a)...


173.357 Materials used as fixing agents in the immobilization of enzyme preparations. Fixing agents may be safely used in the immobilization of enzyme...


Octafluorocyclobutane. The food additive octafluorocyclo-butane may be safely used as a propellant and aerating agent in foamed or sprayed food products...


173.368 Ozone. Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment, storage, and processing of foods, including meat and poultry (unless such use...


Peroxyacids. Peroxyacids may be safely used in accordance with the following prescribed conditions: (a) The additive is a mixture of peroxyacetic...


Sodium methyl sulfate. Sodium methyl sulfate may be present in pectin in accordance with the following conditions. (a) It is present as the result...


173.395 Trifluoromethane sulfonic acid. Trifluoromethane sulfonic acid has the empirical formula CF3SO3H (CAS Reg. No. 1493-13-6). The...


173.400 Dimethyldialkylammonium chloride. Dimethyldialkylammonium chloride may be safely used in food in accordance with the following prescribed conditions: ...


provisions applicable to indirect food additives. 174.6 Threshold of regulation for substances used in food-contact articles. Authority: 21 U.S.C....


in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate, or that may be expected to migrate, into food at negligible levels may be reviewed...


in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate, or that may be expected to migrate, into food at negligible levels may be reviewed...
...


175.125 Pressure-sensitive adhesives. Pressure-sensitive adhesives may be safely used as the food-contact surface of labels and/or tapes applied to food, in...


175.210 Acrylate ester copolymer coating. Acrylate ester copolymer coating may safely be used as a food- contact surface of articles intended for packaging...


Hot-melt strippable food coatings. Hot-melt strippable food coatings may be safely applied to food, subject to the provisions of this section. (a)...


Paraffin (synthetic). Synthetic paraffin may be safely used as an impregnant in, coating on, or component of coatings on articles used in...


Partial phosphoric acid esters of polyester resins. Partial phosphoric acid esters of polyester resins identified in this section and applied on aluminum may...


Poly(vinyl fluoride) resins. Poly(vinyl fluoride) resins identified in this section may be safely used as components of food-contact coatings for containers having...


Poly(vinyl fluoride) resins. Poly(vinyl fluoride) resins identified in this section may be safely used as components of food-contact coatings for containers having...
...


175.320 Resinous and polymeric coatings for polyolefin films. Resinous and polymeric coatings may be safely used as the food- contact surface of articles intended for...


Vinyl acetate/crotonic acid copolymer. A copolymer of vinyl acetate and crotonic acid may be safely used as a coating or as a component of a coating which is...


175.360 Vinylidene chloride copolymer coatings for nylon film. Vinylidene chloride copolymer coatings identified in this section and applied on nylon film may be...


Vinylidene chloride copolymer coatings for polycarbonate film. Vinylidene chloride copolymer coatings identified in this section and applied on polycarbonate film...


175.380 Xylene-formaldehyde resins condensed with 4,4'-isopropylidenediphenol-epichlorohydrin epoxy resins. The resins identified in paragraph (a) of this section may...


Zinc-silicon dioxide matrix coatings. Zinc-silicon dioxide matrix coatings may be safely used as the food- contact surface of articles intended for use in...


176.110 Acrylamide-acrylic acid resins. Subpart A [Reserved] Subpart B_Substances for Use Only as Components of Paper...


176.120 Alkyl ketene dimers. Alkyl ketene dimers may be safely used as a component of articles intended for use in producing, manufacturing, packing,...


176.130 Anti-offset substances. Substances named in paragraphs (b) and (c) of this section may be safely used to prevent the transfer of inks employed in printing...


176.150 Chelating agents used in the manufacture of paper and paperboard. The substances named in paragraph (a) of this section may be safely used in the manufacture...


176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine. The chromium (Cr III) complex of N-ethyl - N...


176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine. The chromium (Cr III) complex of N-ethyl - N...
...


176.180 Components of paper and paperboard in contact with dry food. The substances listed in this section may be safely used as components of the uncoated or...


176.200 Defoaming agents used in coatings. The defoaming agents described in this section may be safely used as components of articles intended for use in...


176.210 Defoaming agents used in the manufacture of paper and paperboard. Defoaming agents may be safely used in the manufacture of paper and paperboard intended...


176.230 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione. 3,5-Dimethyl-1,3,5,2H-tetrahydrothi-adiazine-2-thione may safely be used as a preservative in...


176.250 Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane. Poly-1,4,7,10,13-pentaaza-15-hydrox-yhexadecane may be safely used as a retention aid employed prior to...


176.260 Pulp from reclaimed fiber. (a) Pulp from reclaimed fiber may be safely used as a component of articles used in producing, manufacturing, packing,...


176.300 Slimicides. (a) Slimicides may be safely used in the manufacture of paper and paperboard that contact food, in accordance with the following...


176.320 Sodium nitrate-urea complex. Sodium nitrate-urea complex may be safely used as a component of articles intended for use in producing, manufacturing,...


176.350 Tamarind seed kernel powder. Tamarind seed kernel powder may be safely used as a component of articles intended for use in producing, manufacturing,...


Food Contact Surfaces Sec. 177.1010 Acrylic and modified acrylic plastics, semirigid and rigid. Subpart A [Reserved] Subpart B_Substances for Use...


Food Contact Surfaces Sec. 177.1020 Acrylonitrile/butadiene/sty rene co-polymer. Acrylonitrile/butadiene/styrene copolymer identified in this section may be...


Food Contact Surfaces Sec. 177.1030 Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer. Acrylonitrile/butadiene/styrene/methyl methacrylate...


Food Contact Surfaces Sec. 177.1040 Acrylonitrile/styrene copoly-mer. Acrylonitrile/styrene copolymers identified in this section may be...


Food Contact Surfaces Sec. 177.1050 Acrylonitrile/styrene copoly-mer modified with butadiene/styrene elastomer. Acrylonitrile/styrene copolymer modified...


Food Contact Surfaces Sec. 177.1060 n-Alkylglutarimide/acrylic copolymers. n-Alkylglutarimide/acrylic copolymers identified in this section may be safely used...


Food Contact Surfaces Sec. 177.1200 Cellophane. Cellophane may be safely used for packaging food in accordance with the following prescribed conditions: ...


Food Contact Surfaces Sec. 177.1210 Closures with sealing gaskets for food containers. Closures with sealing gaskets may be safely used on containers intended for...


Contact Surfaces Sec. 177.1211 Cross-linked polyacrylate copolymers. Cross-linked polyacrylate copolymers identified in paragraph (a) of this section may be...


Food Contact Surfaces Sec. 177.1240 1,4-Cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer. Copolymer...


Contact Surfaces Sec. 177.1310 Ethylene-acrylic acid copolymers. The ethylene-acrylic acid copolymers identified in paragraph (a) of this section may be safely...


Food Contact Surfaces Sec. 177.1312 Ethylene-carbon monoxide copolymers. The ethylene-carbon monoxide copolymers identified in paragraph (a)...


Food Contact Surfaces Sec. 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers. Ethylene-1, 4-cyclohexylene dimethylene terephthalate...


Food Contact Surfaces Sec. 177.1320 Ethylene-ethyl acrylate copolymers. Ethylene-ethyl acrylate copolymers may be safely used to produce packaging...


Food Contact Surfaces Sec. 177.1330 Ionomeric resins. Ionomeric resins manufactured from either ethylene-methacrylic acid copolymers (and/or their ammonium,...


Contact Surfaces Sec. 177.1340 Ethylene-methyl acrylate copolymer resins. Ethylene-methyl acrylate copolymer resins may be safely used as articles or components...


Food Contact Surfaces Sec. 177.1345 Ethylene/1,3-phenylene oxyethylene isophthalate/ terephthalate copolymer. Ethylene/1, 3-phenylene...


Food Contact Surfaces Sec. 177.1350 Ethylene-vinyl acetate copolymers. Ethylene-vinyl acetate copolymers may be safely used as articles or components of...


Food Contact Surfaces Sec. 177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers. Ethylene-vinyl acetate-vinyl alcohol copolymers (CAS Reg. No. 26221- 27-2) may...


Food Contact Surfaces Sec. 177.1380 Fluorocarbon resins. Fluorocarbon resins may be safely used as articles or components of articles intended for use in contact...


Food Contact Surfaces Sec. 177.1390 Laminate structures for use at temperatures of 250 [deg]F and above. (a) The high-temperature laminates identified in this...


Contact Surfaces Sec. 177.1395 Laminate structures for use at temperatures between 120 [deg]F and 250 [deg]F. (a) The laminates identified in this section may...


Food Contact Surfaces Sec. 177.1400 Hydroxyethyl cellulose film, water-insoluble. Water-insoluble hydroxyethyl cellulose film may be safely used for packaging food...


Contact Surfaces Sec. 177.1420 Isobutylene polymers. Isobutylene polymers may be safely used as components of articles intended for use in producing,...


Food Contact Surfaces Sec. 177.1430 Isobutylene-butene copolymers. Isobutylene-butene copolymers identified in paragraph (a) of this section may be safely used...


Contact Surfaces Sec. 177.1440 4,4'-Isopropylidenediphenol-epichlorohydrin resins minimum molecular weight 10,000. ...


Contact Surfaces Sec. 177.1460 Melamine-formaldehyde resins in molded articles. Melamine-formaldehyde resins may be safely used as the food-contact surface of...


Food Contact Surfaces Sec. 177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate copolymers. Nitrile rubber modified acrylonitrile-methyl acrylate...


Food Contact Surfaces Sec. 177.1500 Nylon resins. The nylon resins listed in paragraph (a) of this section may be safely used to produce articles intended for use...


Food Contact Surfaces Sec. 177.1500 Nylon resins. The nylon resins listed in paragraph (a) of this section may be safely used to produce articles intended for use...
...


Food Contact Surfaces Sec. 177.1550 Perfluorocarbon resins. Perfluorocarbon resins identified in this section may be safely used as articles or components of...


Contact Surfaces Sec. 177.1555 Polyarylate resins. Polyarylate resins (CAS Reg. No. 51706-10-6) may be safely used as articles or components of articles intended...


Contact Surfaces Sec. 177.1556 Polyaryletherketone resins. ...


Food Contact Surfaces Sec. 177.1560 Polyarylsulfone resins. Polyarylsulfone resins (CAS Reg. No. 79293-56-4) may be safely used as articles or components of...


Food Contact Surfaces Sec. 177.1570 Poly-1-butene resins and butene/ethylene copolymers. The poly-1-butene resins and butene/ethylene copolymers identified in...


Food Contact Surfaces Sec. 177.1580 Polycarbonate resins. Polycarbonate resins may be safely used as articles or components of articles intended for use in...


Food Contact Surfaces Sec. 177.1585 Polyestercarbonate resins. Polyestercarbonate resins may be safely used as articles or components of articles intended for use...


Contact Surfaces Sec. 177.1590 Polyester elastomers. The polyester elastomers identified in paragraph (a) of this section may be safely used as the...


Food Contact Surfaces Sec. 177.1595 Polyetherimide resin. The polyetherimide resin identified in this section may be safely used as an article or component of...


Contact Surfaces Sec. 177.1600 Polyethylene resins, carboxyl modified. Carboxyl-modified polyethylene resins may be safely used as the food-contact surface...


Food Contact Surfaces Sec. 177.1610 Polyethylene, chlorinated. Chlorinated polyethylene identified in this section may be safely used as articles or components...


Contact Surfaces Sec. 177.1615 Polyethylene, fluorinated. Fluorinated polyethylene, identified in paragraph (a) of this section, may be safely used as...


Food Contact Surfaces Sec. 177.1620 Polyethylene, oxidized. Oxidized polyethylene identified in paragraph (a) of this section may be safely used as a component...


Food Contact Surfaces Sec. 177.1630 Polyethylene phthalate polymers. Polyethylene phthalate polymers identified in this section may be safely used as, or...


Food Contact Surfaces Sec. 177.1632 Poly (phenyl enetereph thala mide) resins. Poly(phenyleneterephthalamide) resins identified in paragraph (a) of this section...


Contact Surfaces Sec. 177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-methyl styrene). Poly(p-methylstyrene) and rubber-modified...


Contact Surfaces Sec. 177.1637 Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins. ...


Food Contact Surfaces Sec. 177.1640 Polystyrene and rubber-modified polystyrene. Polystyrene and rubber-modified polystyrene identified in this section may be...


Contact Surfaces Sec. 177.1650 Polysulfide polymer-polyepoxy resins. Polysulfide polymer-polyepoxy res- ins may be safely used as the food-contact surface...


Food Contact Surfaces Sec. 177.1655 Polysulfone resins. Polysulfone resins identified in paragraph (a) of this section may be safely used as articles or components...


Food Contact Surfaces Sec. 177.1660 Poly (tetramethylene terephthalate). Poly(tetramethylene terephthalate) (poly (oxytetramethyleneoxyter- ephthaloyl))...


Contact Surfaces Sec. 177.1670 Polyvinyl alcohol film. Polyvinyl alcohol film may be safely used in contact with food of the types identified in Sec. 176.170(c)...


Food Contact Surfaces Sec. 177.1680 Polyurethane resins. The polyurethane resins identified in paragraph (a) of this section may be safely used as the...


Food Contact Surfaces Sec. 177.1810 Styrene block polymers. The styrene block polymers identified in paragraph (a) of this section may be safely used as articles...


Food Contact Surfaces Sec. 177.1820 Styrene-maleic anhydride copolymers. Styrene-maleic anhydride copolymers identified in paragraph (a) of this section may be...


Food Contact Surfaces Sec. 177.1830 Styrene-methyl methacrylate copolymers. Styrene-methyl methacrylate copolymers identified in this section may be safely used...


Contact Surfaces Sec. 177.1850 Textryls. Textryls identified in this section may be safely used as articles or components of articles, intended for use in...


Contact Surfaces Sec. 177.1900 Urea-formaldehyde resins in molded articles. Urea-formaldehyde resins may be safely used as the food-contact surface of...


Food Contact Surfaces Sec. 177.1950 Vinyl chloride-ethylene copolymers. The vinyl chloride-ethylene copolymers identified in paragraph (a) of this section may...


Contact Surfaces Sec. 177.1960 Vinyl chloride-hexene-1 copolymers. The vinyl chloride-hexene-1 copolymers identified in paragraph (a) of this section or...


Food Contact Surfaces Sec. 177.1970 Vinyl chloride-lauryl vinyl ether copolymers. The vinyl chloride-lauryl vinyl ether copolymers identified in paragraph (a) of...


Food Contact Surfaces Sec. 177.1980 Vinyl chloride-propylene copolymers. The vinyl chloride-propylene copolymers identified in paragraph (a) of this section may...


Food Contact Surfaces Sec. 177.1990 Vinylidene chloride/methyl acrylate copolymers. The vinylidene chloride/methyl acrylate copolymers (CAS Reg. No....


Contact Surfaces Sec. 177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate polymers. The vinylidene chloride/methyl acrylate/methyl methacrylate...


Repeated Use Sec. 177.2210 Ethylene polymer, chloro sulfonated. Ethylene polymer, chlorosulfonated as identified in this section may be safely used as...


Repeated Use Sec. 177.2250 Filters, microporous polymeric. Microporous polymeric filters identified in paragraph (a) of this section may be safely used, subject to...


Repeated Use Sec. 177.2260 Filters, resin-bonded. Resin-bonded filters may be safely used in producing, manufacturing, processing, and preparing food, subject...


Repeated Use Sec. 177.2280 4,4'-Isopropyl idenedi phenol epichloro hydrin thermo setting epoxy resins. 4,4'-Isopropylidenediphenol-epichlo-rohydrin thermosetting...


Repeated Use Sec. 177.2355 Mineral reinforced nylon resins. Mineral reinforced nylon resins identified in paragraph (a) of this section may be safely used...


Repeated Use Sec. 177.2400 Perfluorocarbon cured elastomers. Perfluorocarbon cured elastomers identified in paragraph (a) of this section may be safely used...


Repeated Use Sec. 177.2410 Phenolic resins in molded articles. Phenolic resins identified in this section may be safely used as the food-contact surface of...


Repeated Use Sec. 177.2415 Poly(aryletherketone) resins. Poly(aryletherketone) resins identified in paragraph (a) of this section may be safely used as articles...


Repeated Use Sec. 177.2420 Polyester resins, cross-linked. Cross-linked polyester resins may be safely used as articles or components of articles intended...


Repeated Use Sec. 177.2430 Polyether resins, chlorinated. Chlorinated polyether resins may be safely used as articles or components of articles intended for...


Repeated Use Sec. 177.2440 Polyethersulfone resins. Polyethersulfone resins identified in paragraph (a) of this section may be safely used as articles or components...


Repeated Use Sec. 177.2450 Polyamide-imide resins. Polyamide-imide resins identified in paragraph (a) of this section may be safely used as components of...


Repeated Use Sec. 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins. The poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in paragraph (a) of...


Repeated Use Sec. 177.2465 Polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers. Polymethylmethacrylate/poly(trimethoxysilylpropyl)...


Repeated Use Sec. 177.2470 Polyoxymethylene copolymer. Polyoxymethylene copolymer identified in this section may be safely used as an article or component...


Repeated Use Sec. 177.2480 Polyoxymethylene homopolymer. Polyoxymethylene homopolymer identified in this section may be safely used as articles or components...


Repeated Use Sec. 177.2490 Polyphenylene sulfide resins. Polyphenylene sulfide resins (poly(1,4-phenylene sulfide) resins) may be safely used as coatings...


Repeated Use Sec. 177.2500 Polyphenylene sulfone resins. The polyphenylene sulfone resins (CAS Reg. No. 31833-61-1) identified in paragraph (a) of this section may...


Repeated Use Sec. 177.2510 Polyvinylidene fluoride resins. Polyvinylidene fluoride resins may be safely used as articles or components of articles intended...


Repeated Use Sec. 177.2550 Reverse osmosis membranes. Substances identified in paragraph (a) of this section may be safely used as reverse osmosis...


Repeated Use Sec. 177.2600 Rubber articles intended for repeated use. Rubber articles intended for repeated use may be safely used in producing,...


Repeated Use Sec. 177.2710 Styrene-divinylbenzene resins, cross-linked. Styrene-divinylbenzene cross-linked copolymer resins may be safely used as articles...


Repeated Use Sec. 177.2800 Textiles and textile fibers. Textiles and textile fibers may safely be used as articles or components of articles intended for use...


Repeated Use Sec. 177.2910 Ultra-filtration membranes. Ultra-filtration membranes identified in paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) of this section may...


178.1005 Hydrogen peroxide solution. Subpart A [Reserved] Subpart B_Substances Utilized To Control the Growth...


178.1005 Hydrogen peroxide solution. Subpart A [Reserved] Subpart B_Substances Utilized To Control the Growth...
...


178.1005 Hydrogen peroxide solution. Subpart A [Reserved] Subpart B_Substances Utilized To Control the Growth...
...
...


4-Hydroxymethyl-2,6-di-tert-butylphenol. 4-Hydroxymethyl-2,6-di-tert-butyl-phenol may be safely used as an antioxidant in articles intended for use in contact...


Organotin stabilizers in vinyl chloride plastics. The organotin chemicals identified in paragraph (a) of this section may be safety used alone or in...


178.3010 Adjuvant substances used in the manufacture of foamed plastics. The following substances may be safely used as adjuvants in the manufacture of...


178.3120 Animal glue. Animal glue may be safely used as a component of articles intended for use in producing, manufacturing, packing, processing,...


178.3125 Anticorrosive agents. The substances listed in this section may be used as anticorrosive agents in food-contact materials subject to the provisions of...


178.3130 Antistatic and/or anti fogging agents in food-packaging materials. The substances listed in paragraph (b) of this section may be safely used as...


178.3280 Castor oil, hydrogenated. Hydrogenated castor oil may be safely used in the manufacture of articles or components of articles intended for use in contact...


178.3290 Chromic chloride complexes. Myristo chromic chloride complex and stearato chromic chloride complex may be safely used as release agents in the closure area...


178.3295 Clarifying agents for polymers. Clarifying agents may be safely used in polymers that are articles or components of articles intended for...


178.3295 Clarifying agents for polymers. Clarifying agents may be safely used in polymers that are articles or components of articles intended for...
...


178.3300 Corrosion inhibitors used for steel or tinplate. Corrosion inhibitors may be safely used for steel or tinplate intended for use in, or to be fabricated...


178.3400 Emulsifiers and/or surface-active agents. The substances listed in paragraph (c) of this section may be safely used as emulsifiers and/or...


178.3450 Esters of stearic and palmitic acids. The ester stearyl palmitate or palmityl stearate or mixtures thereof may be safely used as adjuvants in...


178.3480 Fatty alcohols, synthetic. Synthetic fatty alcohols may be safely used as components of articles intended for use in contact with food, and in...


178.3500 Glycerin, synthetic. Synthetic glycerin may be safely used as a component of articles intended for use in packaging materials for food, subject to...


178.3505 Glyceryl tri-(12-acetoxy stearate). Glyceryl tri-(12-acetoxystearate) (CAS Reg. No. 139-43-5) may be safely used as a component of articles intended for use...


178.3520 Industrial starch-modified. Industrial starch-modified may be safely used as a component of articles intended for use in producing, manufacturing,...


178.3530 Isoparaffinic petroleum hydrocarbons, synthetic. Isoparaffinic petroleum hydrocarbons, synthetic, may be safely used in the production of nonfood...


178.3570 Lubricants with incidental food contact. Lubricants with incidental food contact may be safely used on machinery used for producing, manufacturing,...


178.3600 Methyl glucoside-coconut oil ester. Methyl glucoside-coconut oil ester identified in Sec. 172.816(a) of this chapter may be safely used as a processing...


178.3610 a-Methylstyrene-vinyltoluene resins, hydrogenated. Hydrogenated [alpha]-methylstyrene-vinyltoluene copolymer resins having a molar ratio of...


178.3610 a-Methylstyrene-vinyltoluene resins, hydrogenated. Hydrogenated [alpha]-methylstyrene-vinyltoluene copolymer resins having a molar ratio of...
...


178.3650 Odorless light petroleum hydrocarbons. Odorless light petroleum hydrocarbons may be safely used, as a component of nonfood articles intended for use in...


178.3690 Pentaerythritol adipate-stearate. Pentaerythritol adipate-stearate identified in paragraph (a) of this section may be safely used as a lubricant in...


178.3700 Petrolatum. Petrolatum may be safety used as a component of nonfood articles in contact with food, in accordance with the following conditions: ...


178.3710 Petroleum wax. Petroleum wax may be safely used as a component of nonfood articles in contact with food, in accordance with the following conditions: ...


178.3720 Petroleum wax, synthetic. Synthetic petroleum wax may be safely used in applications and under the same conditions where naturally derived petroleum wax...


178.3725 Pigment dispersants. Subject to the provisions of this regulation, the substances listed in this section may be safely used as pigment dispersants...


178.3730 Piperonyl butoxide and pyrethrins as components of bags. Piperonyl butoxide in combination with pyrethrins may be safely used for insect control on bags that...


178.3740 Plasticizers in polymeric substances. Subject to the provisions of this regulation, the substances listed in paragraph (b) of this section may be safely...


178.3750 Polyethylene glycol (mean molecular weight 200-9,500). Polyethylene glycol identified in this section may be safely used as a component of articles intended...


178.3760 Polyethylene glycol (400) monolaurate. Polyethylene glycol (400) monolaurate containing not more than 0.1 percent by weight of ethylene and/or diethylene...


178.3760 Polyethylene glycol (400) monolaurate. Polyethylene glycol (400) monolaurate containing not more than 0.1 percent by weight of ethylene and/or diethylene...
...


178.3780 Polyhydric alcohol esters of long chain monobasic acids. Polyhydric alcohol esters of long chain monobasic acids identified in this section may be...