Description
This guidance represents the Food and Drug Administration’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. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Scope & Applicability
Product Classes
2Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices; Subject of the guidance for food additive petitions and GRAS notices.
Products regulated by FSIS where enzyme suitability must be documented.
Stakeholders
1individuals who conclude if a drug has the intended effect
Regulatory Context
Attributes
3The appropriateness of an enzyme preparation for use in specific food products.
Data required for submission
Sum of all organic compounds in the enzyme preparation.
Related CFR Sections (2)
- 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 →
- 21CFR170.30§ 170.30 Eligibility for classification as generally recognized as 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 of substances directly or indirectly added to food. The basis of such views may be eitherRead full regulation →
See Also (8)
- Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations) (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) (Status: Final)
- Guidance for Industry: Preparation of Food Contact Substance Notifications (Administrative) (Status: Final)
- Guidance for Industry: Preparation of Food Contact Substance Notifications (Toxicology Recommendations) (Status: Final)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Guidance for Industry: Food Additive Petition Expedited Review (Status: Final)
- Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)