Description
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.
Scope & Applicability
Product Classes
1Agents derived from or consisting of microorganisms
Stakeholders
3Party submitting a citizen petition; party evaluating whether a food allergen is of public health importance; Party recommended to conduct systematic reviews and evidence scoring.
Entity responsible for submitting applications under section 524B
The entity providing information for the AFIC process.
Regulatory Context
Attributes
2The purpose the antimicrobial agent is intended to achieve
Sensitivity of microbes of concern to proposed irradiation
Identified Hazards
Hazards
1Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
Related CFR Sections (4)
- 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 →
- 21CFR170.39§ 170.39 Threshold of regulation for substances used in food-contact articles.
(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 migrate, into food will be exempted from regulation as a food additive because it becomes a component of food at levels that are below the threshold of regulatRead full regulation →
- 21CFR170.230§ 170.230 Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect.
In Part 2 of your GRAS notice, you must include:Read full regulation →
- 21CFR120.24§ 120.24 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 Point (HACCP) plans control measures that will consistently produce, at a minimum, a 5 log ( i.e., 10 5 ) reduction, for a period at least as lonRead full regulation →
See Also (8)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (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)
- Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for Industry (Status: Final)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Status: Draft)
- Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices for Enzyme Preparations (Status: Final)
- Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives (Status: Final)