Description
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach can be used if such approach satisfies the requirements of the applicable statutes and regulations. For questions regarding this document contact Andrew Zajac at FDA's Office of Food Additive Safety, Division of Petition Review (HFS-265), 5001 Campus Drive, College Park, Maryland, 20740-3835, 240-402-1267,andrew.zajac@fda.hhs.gov.
Scope & Applicability
Product Classes
2Submitting toxicology reports in support of petitions
Submitting toxicology reports in support of petitions
Stakeholders
2FDA official responsible for coordinating meetings and overseeing reviews.
responsible for justifying omission of studies
Related CFR Sections (4)
- 21CFR71.15§ 71.15 Confidentiality of data and information in color additive petitions.
(a) The following data and information in a color additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filing of the petition is published in the Federal Register or, if the petition is not promptly filed because of deficiencies in Read full regulation →
- 21CFR171.1§ 171.1 Petitions.
(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submRead full regulation →
- 21CFR20.111§ 20.111 Data and information submitted voluntarily to the Food and Drug Administration.
(a) The provisions of this section shall apply only to data and information submitted voluntarily to the Food and Drug Administration, whether in the course of a factory inspection or at any other time, and not as a part of any petition, application, master file, or other required submission or requRead full regulation →
- 21CFR71.1§ 71.1 Petitions.
(a) Any interested person may propose the listing of a color additive for use in or on any food, drug, or cosmetic or for coloring the human body. Such proposal shall be made in a petition in the form prescribed in paragraph (c) of this section. The petition shall be submitted in triplicate (quadrupRead full regulation →
See Also (8)
- Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (Status: Final)
- CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices (Status: Final)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities (Status: Final)
- Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Status: Final)
- Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (Status: Final)
- French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler) (Status: Final)
- Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage (Status: Final)