 |
|
| Guidance for Shell Egg
Cleaners and Sanitizers |
 |
Compounds used to wash and destain shell eggs are potential food additives.
Therefore, they are regulated by the Food and Drug Administration (FDA).
Unfortunately, FDA does not have any published regulations dealing with shell
egg cleaning and destaining compounds.
Since the end of the U.S. Department of Agriculture prior
approval program for nonfood compounds, FDA has provided FSIS with some general
guidelines we can give to companies inquiring about chemicals acceptable for use
in formulating products for cleaning and destaining shell eggs.
- Substances that are Generally Recognized as Safe (GRAS) for use in food (Title 21 of the Code of Federal Regulations (CFR), Parts 182 and 184). They are not specifically limited when used to clean shell eggs. However, they should be used in accordance with Good Manufacturing Practices (GMP) as defined in 21 CFR, Section 182.1.
- Substances regulated for any purpose as food additives in 21 CFR, Parts 172-186. They may be used up to the maximum allowable concentration permitted by the food additive regulations.
- Dyes and pigments regulated as color additives for use in food may be > used provided they are used at levels not to exceed that specified in the > color additive regulations.
Any chemical that does not meet the criteria set forth above would need to be
reviewed by FDA.
FDA regulates antimicrobial agents that are used on raw
agricultural commodities, such as shell eggs, wherever food is prepared,
packaged, or held for commercial purposes. The Environmental Protection Agency
(EPA) regulates antimicrobial agents that are applied in the field, at treatment
facilities where raw commodities are the only food treated and the treatment
does not change the status of the food as a raw agricultural commodity, and
during transportation between the field and such facility. Sanitizers formulated
in compliance with 21 CFR, Section 178.1010 are acceptable for use in sanitizing
shell eggs provided they are registered with EPA for this use. New sanitizers
(i.e., not formulated in compliance with 21 CFR, Section 178.1010) intended for
use on shell eggs that will be used for commercial purposes must be submitted to
the FDA Center for Food Safety and Applied Nutrition for clearance. Questions
regarding sanitizers applied to shell eggs in the field or at a treatment
facility where raw commodities are the only food treated should be
addressed to the Antimicrobial Division, Office of Pesticide Programs, EPA.
For further information, contact (202) 205-0279 or (202) 205-0623.
|
|
|
|
|
|
