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United States Department of Agriculture
Food Safety and Inspection Service
Office of Policy and Program Development
Washington, D.C.  20250-3700 

Labeling and Consumer Protection

 

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.

  1. 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.
  2. 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.
  3. 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 the Labeling and Consumer Protection Staff at Area Code (202) 205-0279 or (202) 205-0623.

 

 

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For Additional Information Contact:

U.S. Department of Agriculture
Food Safety and Inspection Service
1400 Independence Ave.
Room 602 - Annex Building
Washington, DC  20250
Telephone:  202-205-0279
          Fax:  202-205-3625
        Email:  FSIS.Labeling@fsis.usda.gov
Please include your name and/or company name, phone number and complete e-mail address so that we may promptly reply to your inquires.